Biopharmaceutical Manufacturing Industry Skill Standards

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Northeast Biomanufacturing Collaborative [email protected] NSF Award #0501953

Foreward

In April 1995, the first Bioscience Industry Skill Standards were published by the Education Development Center, Inc.1 The project, led by Dr. Judith Leff and funded by the U.S. Department of Education, brought employees from pharmaceutical companies, biotechnology companies and clinical laboratories together to describe the skills, knowledge and attributes of their jobs. I was a working member of the project, with an interest in using the skill standards to generate curricula and instructional materials for two courses that were under development in a new Biotechnology program at the New Hampshire Community Technical College (NHCTC) in Portsmouth, New Hampshire. In July 1994, a grant from the National Science Foundation (NSF) from the new Advanced Technological Education (ATE) program provided equipment for the development of two cornerstone courses to the industry in return for the development of protocols to support a course in Discovery Research and Standard Operating Procedures (SOPs) to support a course in Biomanufacturing. Two additional grants from the Alfred P. Sloan Foundation in 1996 and 1997 placed these hands-on modules on the Internet, creating an interactive lab manual for student/world-wide access at http://biotech.nhctc.edu. Because of their availability on-line, many instructors utilize these modules to build their own courses, particularly the hands-on SOPs to teach biomanufacturing because instructional materials for biomanufacturing are hard to find.

As students graduated from NHCTC’s biotechnology program and went to work, most of them found employment in biomanufacturing because of the many jobs available and the attractive salaries in this field. In the first few years of the program people were employed in the following areas of biomanufacturing: upstream processing, downstream processing, validation, Quality Control biochemistry, Quality Control microbiology, Quality Assurance, process development and enviromental health and safety. Later, the Massachusetts Biotechnology Council published a directory of Careers in Biotechnology2 in which biotechnology jobs were listed with the degrees needed for each job. In that list there were two jobs requiring an Associate degree that did not appear on the list of biomanufacturing jobs taken by NHCTC students. These two jobs are: instrumentation/calibration and facilites technician.

This is the tenth anniversary of NHCTC’s Biotechnology program and most of our students continue to favor employment in biomanufacturing. The need for people trained to meet the requirements of a range of biomanufacturing occupations is growing and will continue to grow at an increasingly rapid pace during coming years as more biotechnology companies move into manufacturing. A large portion of these new jobs will be for biomanufacturing technicians. This situation created the opportunity to up-date the bioscience industry skill standards by developing skill standards for ten biomanufacturing jobs. An NSF ATE grant (NSF #0303030) provided the funds to define what work these technicians do in a range of occupations and what knowledge, skills, and behaviors they need to succeed in these jobs.

This book provides the instructor in biomanufacturing the necessary concrete information to construct curriculum, courses and modules and purchase equipment for education and training for ten biomanufacturing jobs. Additional supporting information and documentation for the Biomanufacturing Skill Standards along with downloadable surveys that can be used to validate skills, knowledge and attributes for these ten biomanufacturing jobs in other areas of the country can be found at www.biomanufacturing.org.

Sonia Wallman NHCTC Portsmouth, New Hampshire January 31, 2005

1 Education Development Center, Inc. 1995 Gateway to the Future: Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories. Education Development Center, Inc. The Institute for Education and Employment 2 Massachusetts Biotechnology Council 2005 Careers in Biotechnology on-line at http://www.massbio.org/directory/careers.

Table of Contents

Development of the Biomanufacturing Industry Skill Standards page i

Biomanufacturing Job Analysis Workshops page ii

Job Analysis Workshop Participants page iii

Validation Survey Participants page iv

Biomanufacturing Traits, Characteristics and Behaviors page vi

Process Development Associate Job Analysis page 1

Validation Specialist Job Analysis page 6

Manufacturing Technician Upstream Job Analysis page 11

Manufacturing Technician Downstream Job Analysis page 17

Instrumentation/Calibration Technician Job Analysis page 21

Chemistry QC Technician Job Analysis page 27

Microbiology QC Technician Job Analysis page 34

Environmental Health/Safety Technician Job Analysis page 38

QA Documentation Coordinator Job Analysis page 41

Facilities Technician Job Analysis page 47

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DEVELOPMENT OF THE BIOMANUFACTURING INUSTRY SKILL STANDARDS These standards were developed as part of a project, supported by the National Science Foundation, to provide technical support for the biotechnology industry, education institutions (community colleges and some high schools and 4-year colleges), and other organizations and partnerships in the Northeast region of the United States. The major partners in this project were New Hampshire Community Technical College (NHCTC) and EDC. The development of the standards took place from spring through winter 2004. It began with workshops in the spring, followed by surveys, distributed in the summer and fall. The results of the surveys were analyzed during early winter.

Job Analysis Workshops The basic information for the standards was obtained in two 2-day workshops, held in May 2004, in which a total of 28 technicians and supervisors representing 10 biomanufacturing occupations participated (see Appendix A). The approach used was a modified DACUM (Designing a Curriculum) process. The participants worked in teams, each representing one occupation, to identify the duty areas (functions), tasks performed, specific competencies required, tools and equipment used, and behavioral traits needed to perform their work. They also identified, for the academic knowledge required, whether the knowledge needed to be only at a basic (B) level (less than six months training and/or experience), intermediate (I) level (less than two years training and/or experience) or advanced (A) level (more than two years training and/or experience), and whether the knowledge needed was conceptual (C) or practical/applied in nature. The participants came from 12 biotechnology companies from five states in the Northeast.

The end products of the workshops were 10 charts, one for each occupation, that included all of the information listed above. All of the completed charts are contained in Appendix A in this booklet.

Surveys Because the information obtained in the workshops represented only a small sample of people, we needed to obtain a larger sample from a broader number of companies to validate the workshop results. We also wanted to obtain additional information to assist educators in using the standards to develop programs, courses, and curricula.

We reformatted the charts into 10 separate surveys, and e-mailed them to over 170 biomanufacturing technicians, supervisors, and managers in a number of biotechnology companies in the Northeast and Mid-Atlantic regions. We received 57 completed surveys from 15 companies in six Northeast and Mid-Atlantic region states. Respondents were asked to rate the importance of each of the competencies on a 4-point scale, and to indicate, for each competency, the amount of training and/or experience required to perform at a proficient level. The answers to these questions, which are summarized in Appendix C, provide additional information for people developing programs, courses, and modules.

We analyzed the survey responses and made some revisions to the workshop charts based on those responses. If all or most of the respondents indicated that a particular competency, or occasionally a whole task, ranked very low in importance, we deleted it from the chart. Likewise, if almost no one ranked a particular competency, we concluded that that competency was not performed enough to be included, and we deleted it. We did, however, keep competencies that were ranked by a number of people as needing very little training or experience. These are sometimes important competencies, but usually ones that can be learned very quickly, either as part of an introductory-level course or on the job. The charts in this booklet reflect all of these revisions.

Biomanufacturing Job Analysis Workshops

Participants, Their Occupations, and Companies

Education Development Center, Inc., Newton, Mass., May 6–7, 2004 Facilitator: Judith Leff, Education Development Center, Inc. Sponsor: New Hampshire Community Technical College and Education Development Center, Inc.

Megan Amaral Scott Fossier Angel Mercado Validation Engineer II Validation Project Manager Manufacturing Operator Amgen, Inc., West Greenwich, R.I. Lonza Biologics, Portsmouth, N.H. CuraGen Corporation, Branford, Conn.

Rohan Anderson Erin Giaccone Michael Mikolajczak Manufacturing Operator Process Development Associate Calibration/Instrumentation Supervisor Biogen Idec Inc., Cambridge, Mass. Glycofi, Inc., Lebanon, N.H. Amgen, Inc., West Greenwich, R.I.

Jim Baillargeon Jon Hardy Andrew O’Donnell Calibration/Instrumentation and Facilities Manufacturing Operator Calibration/Instrumentation Technologist Manager Lonza Biologics, Inc., Portsmouth, N.H. Wyeth Biopharma, Andover, Mass. Dow Pharmaceuticals, Smithfield, R.I. Scott Kelley Scott Sharland William Falk Manufacturing Operator Manufacturing Operator Metrology Coordinator Wyeth Biopharma, Andover, Mass. Amgen, Inc., West Greenwich, R.I. AstraZeneca Pharmaceuticals, Westborough, Mass. Tony Laccetti Jeffrey Ucran Process Development Associate Manufacturing Technician Lawrence Forman Biopure Corporation, Cambridge, Mass. Wyeth Biopharma, Andover, Mass. Process Development Specialist CuraGen Corporation, Branford, Conn.

New Hampshire Community Technical College (NHCTC), Portsmouth, N.H., May 17–18, 2004 Facilitator: Judith Leff, Education Development Center, Inc. Sponsor: New Hampshire Community Technical College and Education Development Center, Inc.

Claire Arsenault Judy Franklin Jack Shaw QC Microbiology Technician QC Chemistry Technician Environmental Health and Safety Wyeth Biopharma, Andover, Mass. BioProcessing Inc., Scarborough, Maine Specialist Stryker Biotech, Lebanon, N.H. Richard Austin Josh Getchell Environmental Health and Safety QC Chemistry Technician Donald Taylor Training Specialist Lonza Biologics Inc., Portsmouth, N.H. Facilities Technician Amgen, Inc., West Greenwich, R.I. Stryker Biotech, Lebanon, N.H. Kathleen Lang Scott Brouillard QA Documentation Supervisor Scott True Facilities/Maintenance Training Specialist Genzyme Corporation, Cambridge, Mass. QC Microbiology Technician Amgen, Inc., West Greenwich, R.I. Lonza Biologics, Portsmouth, N.H. Edmond Le Duc Joseph Denton QC Microbiology Technician Sue Veal QA Documentation Coordinator Wyeth Biopharma, Andover, Mass. QA Documentation Manager Amgen, Inc., West Greenwich, R.I. Lonza Biologics, Portsmouth, N.H.

Kris Evon QC Chemistry Technician Amgen, Inc., West Greenwich, R.I. ii

Companies and Education Institutions Participating in Job Analysis Workshops

Companies

Amgen Inc. AstraZeneca Pharmaceuticals LP West Greenwich, RI Westborough, MA

Biogen Idec Bioprocessing Inc. Cambridge, MA Scarborough, ME

Biopure Corporation CuraGen Corporation Cambridge, MA Branford, CT

Dow Pharmaceuticals Genzyme Corporation Smithfield, RI Cambridge, MA

GlycoFi, Inc. Lonza Biologics Inc. Lebanon, NH Portsmouth, NH

Stryker Biotech Wyeth BioPharma West Lebanon, NH Andover, MA

Education Institutions

New Hampshire Education Development Center, Inc. Community Technical College Newton, MA Portsmouth, NH

Middlesex Community College Community College of Rhode Island Bedford, MA Warwick, RI

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Companies and Education Institutions Participating In Standards Validation Survey

Companies

Amgen Inc. AstraZeneca Pharmaceuticals West Greenwich, RI LP Westborough, MA Biogen Idec Centocor, Inc. Cambridge, MA Malvern, PA

Charles River Laboratories CuraGen Corporation Wilmington, MA Branford, CT

Dow Pharmaceuticals Formatech, Inc. Smithfield, RI Andover, MA

Genzyme Corporation GlaxoSmithKline Cambridge, MA Upper Merion, PA

Immune Response Corporation Lonza Biologics King of Prussia, PA Portsmouth, NH

Nabi Pharmaceuticals Stryker Biotech Rockville, MD West Lebanon, NH

Wyeth BioPharma MdBio Andover, MA Frederick, MD

Education Institutions

Education Development New Hampshire Community Center, Inc. Technical College Newton, MA Portsmouth, NH

Middlesex Community Minuteman Technical High College School Bedford, MA Lexington, MA

Community College of Montgomery County Rhode Island Community College Warwick, RI Blue Bell, PA

CityLab, Boston University

Medical School

Boston, MA

Demographic Summary of Respondents

Size of Company Represented

7% small (1-49 employees) 11% medium (50-99 employees) 82% large (100+ employees)

Job Category Represented

14% managers 28% supervisors 58% technicians

Regions Represented by Companies

77% - Northeast state (MA, NH, RI, CT) 24% - Mid-Atlantic states (MD, PA)

TRAITS, CHARACTERISTICS, AND BEHAVIORS REQUIRED FOR BIOMANUFACTURING OCCUPATIONS

This list was created by representatives of ten different Biomanufacturing Occupations in 2 Job Analysis Workshops, held in May, 2004. The Workshop Participants agreed that all of these Traits and Behaviors were required for all of the 10 Occupations Analyzed.

Ability to Follow Directions Intelligence Ability to Maintain Perspective Leadership Ability to be Self Critical Maturity Ability to Take Criticism Mechanical ability Ability to Handle Stress Motivation (to do the work) Ability to Take Initiative Multi-tasking Ability Approachability Persistence Assertiveness Physical Energy Attention to Detail Preciseness Common Sense Problem Solving Ability Conflict Management/ Resolution Skills Organizational skills Consistency Resiliency Creativity Resourcefulness Curiosity/Ability to Question Respectfulness Dedication Respect for Authority Dependability Responsibility Diversity Understanding Self-Confidence Drive/Determination Self-Control Endurance Sense of Humor Flexibility/Adaptability Sense of Ownership Friendliness Tactfulness Generosity Team Player Honesty Tenacity Initiation Willingness to Learn Integrity Work ethic

Job Functions, Tasks, and Competencies of PROCESS DEVELOPMENT ASSOCIATE Evaluates, improves, and assists with scale-up manufacturing processes and technologies in order to improve product yield and reduce overall costs of production.

JOB FUNCTIONS COMPETENCIES

1. Manage Raw Materials/

Consumables Task A: Maintain order d Obtain/order a Create database b Keep database c Check supplies appropriate chemicals and supplies as for chemicals updated periodically consumables necessary Task B: Identify Materials for a Read and follow b Make list or c Gather materials

Protocols protocols obtain BOM order, if necessary 2. Maintain Lab/Pilot

Equipment a Become familiar b Replace parts c Replace parts Task A: Replace parts per SOP with equipment and periodically as according to use manuals required b Gather and Task B: Clean and sanitize per a Document prepare c Perform cleaning d Record actions SOP/manual everything reagents/equipment c Perform periodic Task C: Standardize equipment to a Document b Gather and or task-specific d Record actions specs everything prepare reagents standardization a Develop schedule Task D: Perform routine b Gather for equipment c Perform work d Record actions maintenance tools/materials maintenance 3. Perform Analytical Testing b Perform a Collect samples Task A: Test water purity analytical testing; c Record actions per procedure submit to lab c Check Task B: Test buffer/media quality a Check pH b Check osmolality d Record results conductivity e Perform g Perform Task C: Perform product quality a Prepare samples b Perform SDS c Perform HPLC d Perform ELISA Isoelectric f Perform UV/visible assays for specific test electrophoresis analysis assays Focusing endotoxin testing spectroscopy electrophoresis b Analyze trace Task D: Analyze media a Analyze amino c Check components (send components acids via HPLC pH/osmolality to outside) a Perform Task E: Perform product c Perform Bradford spectroscopy b Perform ELISA concentration assays assay (A280)

JOB FUNCTIONS COMPETENCIES

4. Prepare Final Material for Animal Studies Task A: Follow protocols to a Obtain training b Prepare e Store c Execute activity d Harvest cells produce upstream intermediate on procedures fermenters/reagents intermediate b Perform chromatography/fil c Prepare bulk Task B: Follow procedures to a Obtain training tration steps as material final produce downstream product on procedures required by formulation protocol 5. Maintain Cultures/Cell Banks Task A: Prepare cell banks per b Maintain storage e Add f Freeze cells a Maintain stock d Centrifuge/ SOP and control rate c Grow cell lines cryoprotectants to according to g Record activities culture database resuspend cells freezers cells procedure. a Gather materials d Centrifuge/ Task B: Prepare cell cultures per b Use aseptic c Grow cell lines as and shaker resuspend cells if e Record activities SOP techniques needed equipment required 6. Prepare Documentation d Record all a Train on b Use ink for all c Sign and date all e Have entries Task A: Maintain lab notebook process-/ product- notebook procedure recording recordings countersigned related activities a Perform company Task B: Update and revise SOPs change control as needed procedure a Summarize Task C: Write development specific project reports/summaries work findings Task D: Maintain a Keep training training/continuing education records in folder documents for internal review 7. Prepare Buffers/Media a Perform daily b Obtain containers d Weigh reagents Task A: Weigh and dispense c Check for proper scale calibration for weighing per scale operation reagents reagent quality check reagents procedure Task B: Test for buffer/media c Check a Check pH b Check osmolality d Record results quality conductivity a Assign lot Task C: Label and assign lot number , expiration number and date date and sign label a Prepare c Perform equipment (i.e., b Follow procedure calculation to d Filter e Follow Task D: Follow SOP/recipe for tanks, flasks, for weighing determine buffer/media prior procedure; Adjust specific buffer/media mixers containers, reagents component for the to use pH, if necessary bags) buffers/media

JOB FUNCTIONS COMPETENCIES

b If pH outside c If solution neutral range, contains hazardous Task E: Dispose of material a Check pH dispose of per material, dispose of appropriately hazardous waste per hazardous procedure waste procedure 8. Design and/or Implement

Experiments a Review scientific/ b Use technical literature Internet/library Task A: Perform literature search prior to designing resources to experiments perform search a Communicate Task B: Consult with colleagues b Record suggested with peers on ideas on experimental objectives ideas for study a Prepare b Prepare chromatography/ Task C: Prepare materials and fermentation/cell c Prepare filtration equipment equipment culture equipment buffers/media for purification for experiments required a Record b Sample at Task D: Follow experimental c Perform observations in experimental procedures and design appropriate assays notebook conditions c Record a Create Excel b Plot results in results/formulate d Compose report, Task E: Analyze results spreadsheet charts and tables conclusions in lab if required notebook 9. Write and/or Implement

Approved Protocols b Consult with Task A: Develop protocols from a Review prior peers/supervisors prior experiments experiments/data prior to writing c Analyze samples a Follow the b Take samples as d Record Task B: Execute the protocol as required; record procedure needed observations results b Note deviations a Ensure all steps and fill out c Construct final Task C: Complete protocol are signed and appropriate report and have documentation reviewed deviation signed documentation c Record a Create Excel b Plot results in results/formulate d Compose report, Task D: Analyze results spreadsheet charts and tables conclusion in lab if required notebook

JOB FUNCTIONS COMPETENCIES

10. Prepare Experimental Equipment b Clean process c Check pH to equipment (e.g., determine if Task A: Clean and sterilize per a Autoclave as chromatography, cleaning agents

SOPs necessary TFF filters, tanks have been properly with chemical removed prior to cleaners) use a Obtain equipment b Confirm integrity c Build apparatus Task B: Construct testing (e.g., pumps, of assembled per experimental equipment as appropriate tubing, filters) systems design Order if necessary b Perform or Task C: Ensure instruments are a Check records for schedule calibrated calibration data calibration as required 11. Ensure Safe Working

Environment a Schedule training Task A: Obtain training regarding by certified b Report problems safety personnel a Housekeeping; c Clean up spills Task B: Maintain a safe b Wear PPE as d Keep a clutter put everything in according to proper laboratory necessary free work area proper place procedure a Bring material to b Report full Task C: Follow procedures for assigned area for containers to safety disposal of hazardous materials disposal officer for removal

Knowledge, Skills, and Equipment Process Development Associate

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Aseptic Technique, Biosafety Cabinet, Clean Room Autoclave Incubators B – Basic I – Intermediate A – Advanced Audit Preparation Automated cell counters Laboratory Gases Communication Balances Laminar Flow Hoods Key to Type of Knowledge/Skill Required: Computer Science Centrifuges Microscope/ C – Conceptual P – Practical/Applied Documentation Chromatography hemacytometer Ergonomics Level Type Columns Mixers GMPs Clean Steam Osmometer Biochemistry and Lab ...... B Industrial C Safety Conductivity meter pH meter Biology ...... B Mechanical C Controlled Rate Pipeters Chemistry and Lab ...... B Organization C Cryogenic Freezers Pipettes Computer Science...... B Problem P Solving Cryogenic Storage Plate Reader Electronics ...... B Time P Management Freezers Pressure Gauges Math (Algebra I,II, Statistics) ...... I P Depth Filters Pumps Microbiology/Cell Biology and Lab ...... I C Fermenters Shakers Organic Chemistry and Lab ...... B C Filtration Hardware Spectrophotometer Physics and Lab ...... B C Flow Cytometry Sterile Packaging Principles in Mechanical/ Flow Sensors Sterilizing Grade Filters Chemical Engineering ...... B C Flow Through Stir Plates Technical Writing ...... B P Instrumentation Tangential Flow Filters Gel Electrophoresis/ Temperature Monitors Western Apparatus Valves Glass Washer Water Purification System Gradient Makers Graduated Cylinders/ Volumetric Flasks Homogenizer HPLC

Job Functions, Tasks, and Competencies of VALIDATION SPECIALIST Develops, recommends strategies, and designs studies to validate and document effectiveness of systems, equipments, methods, or processes. Conducts processes and qualification programs.

JOB FUNCTIONS COMPETENCIES 1. Write Protocols c Identify e Identify piping a Identify major b Identify valve d Identify f Identify system Task A: Read P&IDs utilities to major use material and components types instruments boundaries components spec a Identify b Identify c Determine Task B: Read and extract component corrective/ component information Manuals critical preventative operation parameters maintenance a Read and apply b Read and apply c Read and apply d Determine Task C: Practice use of pertinent information from information from acceptance equipment/ processes/utilities information from software process criteria system SOPs specifications description a Read and b Read and d Develop Task D: Read/make use of c Develop utilize user utilize software software life information from software traceability requirement design cycle code specifications matrix specifications specifications requirements a Maintain Task E: Make use of current b Identify information from industry c Interpret d Assess knowledge on applicable standards and regulatory regulations regulatory risk product regulations requirements requirements a Work with process b Extract c Identify Task F: Extract information development to information from sources of data from process requirements determine validation collection/ process guidelines information parameters 2. Execute Protocols a Learn basic b Apply GMP Task A: Document results appropriate units documentation of measure practices Task B: Measure pipe a Read isometric b Read P&IDs sloping/sizes drawings c Identify e Identify piping Task C: Read/walk-down a Identify major b Identify valve d Identify f Identify system utilities to major use material and P&IDs components types instruments boundaries components spec

JOB FUNCTIONS COMPETENCIES e Use knowledge c Set up and of steam f Restore h Download data extract dynamics to equipment to its g Verify Task D: Used data loggers to a Connect wires b Calibrate data d Place from PC or data information from assess impact of original state calibration of collect temperature data to data logger logger thermocouples logger to analyze data logger TC placement (i.e., leave it how thermocouples data software and restriction of you found it) steam flow f Use knowledge g Complete e Swab of environmental b Apply aseptic d Use the proper paperwork and h Label a Apply proper c Use knowledge equipment impact to techniques for sample documentation containers with Task E: Collect samples use of sanitary of proper storage surfaces for samples (i.e., collecting containers for the for submission appropriate utility systems of sample residual soiling contamination samples testing required and testing of information components not related to the samples study) a Use DCS b Use PLC c Use BAS Task F: Test software d Use databases system systems system d Verify a Check b Check wire Task G: Perform loop checks c Check address component continuity labels response a Apply c Generate spreadsheet b Calculate graphical Task H: Compile data/graphs software d Identify data conditions for representation of and spreadsheets knowledge (e.g., source/location saturated steam data (e.g., time max, min, vs. temperature) average) a Apply d Communicate c Consider knowledge of b Make use of change in impact of other Task I: Schedule execution scheduling/ time schedules to activities on activities project management stakeholders/ these planned management skills equipment activities software owners c Inspect entry a Obtain b d Organize team e Test confined equipment (e.g., Task J: Prepare for entry into confined space Complete/obtain for entry (e.g., space g Enter confined h Restore ropes, fall f Verify LOTO confined spaces entry training approval of entry rescue, entrant, environment space confined space protection, and certification permit attendant) (e.g., air) harness) e Communicate b Use personal c Follow LOTO f Unlock Task K: Comply with LOTO a Obtain LOTO d Ensure systems to individuals or issued locks procedure for equipment when and other safety procedures training are de-energized when LOTO and tags equipment work is complete impacts b Apply a Gather and technical writing review Task L: Write summary skill to c Obtain information, reports summarize data approvals data, and test and draw results conclusions

JOB FUNCTIONS COMPETENCIES e Use particle a Use b Use pressure Task M: Measure c Use flow meter d Use boroscope counters; slit to thermometer or gauge or temperature, pressure, and to check flow to inspect piping agar air sampler thermocouples thermohygromet humidity rates and equipment (viable air with data logger er sampler) e Apply c Apply d Apply knowledge of a Apply basic knowledge of b Apply basic knowledge of equipment/ microbiology room Task N: Gown for controlled personal hygiene different personnel flow knowledge to classifications areas to assure areas/products to and requirements assure and how cleanliness prevent cross- for movement cleanliness gowning may be contamination from one area to different another 3. Carry Out Investigation a Follow c Document b Define failure d Document procedure for chronology of Task A: Document failures and compare to immediate documenting events leading up expected results actions taken failure to the failure d Document a Initiate b Review c Identify all Task B: Identify root cause of rationale for investigation of supporting data potential causes failures identified cause failure and test results of the failure of failure b Document c Document a Repeat rationale if no justification if Task C: Assess validation if no impact to validation does product/validation impact root cause is product is not require determined determined repeating a Obtain b Coordinate Task D: Resolve c Schedule re- approvals of action plan with d Implement failure/identify corrective qualification failure impacted corrective action action activities documentation departments 4. Provide Technical

Assessment c Write technical Task A: Assess a Review b Review assessment of equipment/process changes for proposed applicable change and validation impact changes validation conclude impact c Write technical Task B: Assess b Review a Review assessment of deviation/non-conformance applicable deviation deviation and for validation impact validation conclude impact c Write technical Task C: Assess changes to b Review assessment of standard operation procedures a Review SOP applicable document for validation impact validation change and conclude impact

JOB FUNCTIONS COMPETENCIES 5. Use PC Skills e Write weekly/ a Write protocols b Write reports c Write SOP d Write plans monthly status Task A: Perform word using word using word using word using word reports using processing processing tool processing tool processing tools processing tools word processing tools b Perform c Write macros d Import tables Task B: Create and use a Analyze data calculations with to facilitate into reports and spreadsheets formulas tedious tasks presentation c Import Task C: Create and use charts b Graphically graphs/charts a Analyze data and graphs present data into reports and presentations a Track approval b Track c Trend d Generate Task D: Maintain database of validation validation of deviations reports/ queries documents equipment a Identify project b Identify c Identify task D Track task e Update status Task E: Use project software tasks resources durations completion of project b Create c Create diagram Task F: Use flow charting a Create diagram sequence of of system software of process flow activities boundaries

Knowledge, Skills, and Equipment Validation Specialist

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Clean Room Air Monitor (For Vessel Entry) B – Basic I – Intermediate A – Advanced Communication Air Particle Counter Computer Applications Air Sampler (For Environmental Sampling) Key to Type of Knowledge/Skill Required: Documentation Biological Indicators C – Conceptual P – Practical/Applied Ergonomics Boroscope GMPs Level Type Calculators Handle Audits Computers Biology ...... B IndustrialC Safety Datalogger (Digistrip, Validator 2000, Temptails) Chemical Engineering ...... B MechanicalC Digital Protractor Chemistry ...... B OrganizationC Flow Meters Computer Science ...... B ProblemC Solving Multimeter Electronics ...... B TimeP Management Personal Protective Equipment (Safety Glasses, Safety Shoes, Math ...... B C Gloves, Harness, Fall Protection) Mechanical/Electrical Engineering ...... B P Pressure Gauge Microbiology ...... B C Saturated Steam Tables Physics ...... B C Thermocouples Plumbing (Drawings) ...... B C Thermohygrometer Statistics ...... B P Wet Bulb Technical Writing ...... B P

Job Functions, Tasks, and Competencies of MANUFACTURING TECHNICIAN (UPSTREAM) Conducts specific manufacturing operations, such as cell culture and growth, fermentation, preparation of media, and buffer components; assists with in-process testing

JOB FUNCTIONS COMPETENCIES 1. Perform Cell

Culture/Fermentation d Inoculate f Scale-up a Take master c Add media to Task A: Establish working spinner flask e Put spinner culture to g Dispense into h Put vials into cell bank vial out b Thaw vial autoclaved cell bank with contents of flask in incubator fermentor vials cryo-unit of cryo-unit spinner flask vial volume d Inoculate f Incubate a Take working c Add media to spinner flask e Put spinner spinner for Task B: Perform vial thaw cell bank vial out b Thaw vial autoclaved with contents of flask in incubator desired length of of cryo-unit spinner flask vial time c Aliquot culture e Send used a Remove b Add media to from initial d Incubate larger spinner to Task C: Perform scale-up ops spinner from next larger size spinner into spinners equipment prep incubator spinner flasks larger spinner for turnaround flasks d Once port has a Add growth f Send used b Connect cooled, transfer e Perform post- Task D: Inoculate seed media to c Steam feed spinner to spinner flask to contents of steaming of feed reactor sterilized seed port of reactor equipment prep seed reactor spinner into seed port reactor for turnaround reactor e Transfer a Add media to f Perform post- Task E: Inoculate perfusion b Steam transfer c Allow transfer d Check for contents of seed sterilized steaming of reactor line line to cool positive pressure reactor to perfusion reactor transfer line perfusion reactor a Add production e Transfer media to contents of f Perform post- Task F: Inoculate production b Steam transfer c Allow transfer d Check for sterilized perfusion reactor steaming of reactor line line to cool positive pressure production to production transfer line reactor reactor a Pressure test b Sterilize filter media filter c Allow d Add desired Task G: Perform media assembly and e Perform post- f Disassemble assembly and assembly and media volume to addition transfer line/feed steaming filter assembly transfer line/feed line to cool reactor port port b Run culture d Check display e Adjust set c Visually Task H: Monitor culture tests to confirm and trends for points as a Sample reactor inspect reactor parameters process proper process necessary to culture parameters parameter optimize culture b Aseptically d Label, store, a Prepare sample Take sample c Aliquot e Make LIMS Task I: Execute sampling and submit apparatus using appropriate required samples entries as needed sample sampling device Copyright © 2006 Northeast Biomanufacturing Center Page 11

JOB FUNCTIONS COMPETENCIES 2. Follow Safety Procedures c Follow safety a Check MSDS Task A: Wear appropriate b Don procedures or relevant safety apparatus appropriate attire relevant procedure to task b Fill out work e Be familiar a Assess order for Task B: Maintain safe c Ensure floors d Reduce clutter with location of condition of hazardous working environment are dry in work area nearest safety working area conditions, if station necessary b Verbally communicate to c Notify EH&S a Notify Task C: Communicate coworkers and of potential supervisor of any potential hazards oncoming shift hazards or near near misses the details of misses potential hazards a Check database b Attend safety c Complete Task D: Keep safety training for your status trainings and paperwork for up to date on a regular meetings as safety trainings basis required 3. Follow GMPs a Fill out b Sign c Submit d Perform any required paperwork to Task A: Maintain training paperwork to required documentation show that you records training electronic as you become have read and department training proficient understood SOPs a Review most b Identify any c Fill out change Task B: Update procedures as current revision d Submit request e Sign new necessary request and required to verify for approval revision changes revise document accuracy d Ensure verifier a Obtain correct b Perform task as c Document in a Task C: Follow documented and documents procedure and written in timely manner as procedures are present, revision for task procedure required when required a Document and b Ensure verifier perform tasks in Task D: Fill out batch records is present for order as in a timely manner tasks requiring a specified in verifier batch record a Don’t back b Don’t forge c Document data d Don’t falsify date directly from data Task E: Perform tasks in an source ethical manner

JOB FUNCTIONS COMPETENCIES

4. Use PC Skills a Obtain data Task A: Enter data for b Enter data into from batch process parameters correct database record d Enter any b Select e Ensure f Ensure manual g Acknowledge Task B: Operate process a Follow c Download specific process appropriate operation runs configurations prompts as automation procedure recipe parameters recipe properly are correct needed required b Fill out required c Describe Task C: Fill out work order a Obtain work d Describe work information identified e Submit request request order form needed to repair using appropriate problem database b Type up c Fill out a Obtain required steps to d Obtain Task D: Create/revise document e Submit for document perform appropriate procedures revision request approval template in Word procedure signatures form sequentially 5. Perform Sterilization f Upon completion of B Manipulate c Drain glycol sterilization a Ensure e Ensure all set Task A: Sterilize vessels and valves to from vessel d Run automated phase, g Document as pressure test has points are transfer lines specified jacket, if recipe manipulate required been performed reached orientation applicable valves during cool-down as specified b Run Task B: Sterilize sample a Attach sterile d Sample from sterilization per c Cool per SOP device/port sampling device device SOP Task C: Autoclave equipment a Assemble b Load e Ensure process f Close valves c Select (same procedure for equipment per equipment into d Run cycle parameters are and unload appropriate cycle depyrogenation ovens) procedure chamber met equipment 6. Clean Equipment b Obtain required a Ensure that c Set up d Run cleaning Task A: Clean CIP vessels, equipment/cleani CIP skid is ready equipment as operation per e Disassemble transfer lines, and filter trains ng solutions such for operation required SOP as hoses ,pump etc a Set up c Complete b Open WFI Task B: Perform WFI flush of appropriate manual supply per d Disassemble transfer lines valves, hoses, manipulations procedure etc. per procedure

JOB FUNCTIONS COMPETENCIES a Prepare b Place Task C: Clean COP c Soak for d Rinse with solution in COP equipment into equipment (or sonicator) specified time WFI tank bath b Load d Remove Task D: Wash glassware a Prepare c Run e Prepare or equipment into equipment and equipment glasswasher appropriate cycle wrap equipment glasswasher allow to dry b Wipe down equipment c Wipe down d Wipe down Task E: Perform scheduled a Prepare surfaces starting surfaces with surfaces with sanitizations of hoods disinfectant from cleanest to water IPA dirtiest 7. Prepare Buffers and

Medias d Place raw b Obtain raw material in Task A: Weigh components a Calibrate scale c Tare container e Close container material container to specified weight b Perform a Move materials d Place batch inventory c Record on Task B: Dispense components to appropriate record with transaction for batch record storage area materials movement a Ensure systems g Store at have been f Filter and specified b Obtain raw c Charge batch d Add specified e Mix for Task C: Prepare batch sterilized and transfer to temperate and materials vessel with WFI raw materials specified time prepared as storage vessel assign expiration necessary date 8. Perform Testing Task A: Test integrity of b Set up and d Check for a Wet filters c Execute test filters attach tester passing results b Pressurize d Monitor e Ensure that a Set-up f Release Task B: Perform pressure test equipment to c Check for leaks pressure loss for passing criteria equipment pressure desired pressure specified time are met c Standardize b Prepare probes Task C: Use testing probes a Obtain probes probes per for use procedure c Run sample on Task D: Perform in-process b Aliquot sample a Obtain sample applicable d Record results testing as required meters a Obtain sample d Pipette sample e Count cells b Dilute sample Task E: Perform cell counting and c Vortex sample onto under in trypan blue hemacytometer hemacytometer microscope 9. Perform Recovery/

Filtration a Buffer b Download c Initiate d Monitor trans- e Sample as Task A: Run TFF skid flush/equilibratio appropriate operation per membrane necessary n recipe procedure pressure

JOB FUNCTIONS COMPETENCIES a Ensure filters have been Task B: Perform depth b Charge d Monitor steamed and are c Bleed filters filtration solution to filters filtration ready for processing Task C: Perform a Set up b Get bowl up to c Start feeding d Monitor e Adjust dislodge centrifugation centrifuge speed product centrifuge a Set-up c Apply pressure d Run 2 to 3 e Monitor Task D: Run homogenizer b Start feeding homogenizer to pistons feeds operation 10. Maintain

Communication c Pass update Task A: Deliver shift change a Compose shift b Pass update on onto oncoming update change update to Supervisor shift b Contact Task B: Contact appropriate a Determine appropriate groups for specific needs needs groups for specific needs

Knowledge, Skills, and Equipment Manufacturing Technician (Upstream)

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Cleanroom Experience Autoclaves B – Basic I – Intermediate A – Advanced Communication Bio-Safety Cabinet And Laminar Flow Computer Applications Hood Key to Type of Knowledge/Skill Required: Documentation Blood Gas Analyzer C – Conceptual P – Practical/Applied Ergonomics Centrifuge GMPs Chart Recorders Level TypeHandle Audits CIP Skids Industrial Safety Computers Biology ...... B CMechanical Conductivity Meter Chemistry ...... B POrganization Filter Integrity Tester Computer Sciences ...... B PProblem -Solving Filtration Devices Math ...... B CTime Management Gas Cylinders Microbiology ...... B P Hemocytometer Or Automated Cell Plumbing ...... B P Counter Technical Writing ...... B P Homogenizer Incubators Liquid Nitrogen Containers Microscope Osmometer Peristaltic Pumps And Other Pumps Ph And DO Probes Ph Meter Pipettes Pressure Gauges Regulators Rupture Discs Scales And Balances Shakers And Rockers Spectrophotometer Steam Traps Stir Plates Valves And Piping Water Baths

Job Functions, Tasks, and Competencies of MANUFACTURING TECHNICIAN (DOWNSTREAM) Conducts specific manufacturing operations, such as CIP/SIP of equipment, column chromatography, ultrafiltration, diafiltration, protein purification operations, monitoring control devices

JOB FUNCTIONS COMPETENCIES

1. Adhere to GMPs b Don gowning a Enter gown materials in Task A: Gown personnel room correct order per SOP c Record and report all b Use procedures Task B: Follow procedures a Train on SOP deviations from to do tasks normal processing b Identify e Document a Find qualified c Conduct Task C: Train personnel deficient area for d Assess trainee training trainer training training procedure or task b Document c Verify d Record and e Document Task D: Complete batch a Perform task appropriately independently capture events events in real documentation per procedure into batch that task was accurately and time document done accurately clearly a Obtain b Verify that all d Distribute to Task E: Review batch c Sign document completed entries are Quality documentation as completed documentation accurate Assurance Task F: Label and apply c Record d Attach to status to equipment and a Obtain labels b Identify status accurately equipment materials a Exchange h Use information c Complete task f Voice concerns g Plan between communication Task G: Maintain open lines b Organize tasks d Comprehend e Respect efficiently about in framework of to upper functional tools effectively of communication assigned assigned tasks authority status of work a team management departments (e- day mail/voicemail) b Follow f Report all c Review MSDS Task H: Maintain safe appropriate d Clean spills in e Dispose of incidents to g Adhere to a Use PPE guidelines as working environment safety real time waste properly safety alarms necessary procedures department 2. Prepare Solutions d Determine f Formulate b Verify from amount of raw e Dispense in solution by a Obtain raw label that c Standardize Task A: Weigh raw materials material needed appropriate mixing material required material is balance from batch environment dispensed released for use documentation materials

JOB FUNCTIONS COMPETENCIES

b Filter into a Use Task B: Filter solutions appropriate appropriate filter vessel b Ensure for Task C: Sample and test a Remove in- passing results solution process assays prior to transfer b Transfer under Task D: Transfer solution to a Identify appropriate use point receiving area conditions 3. Clean Environment and

Equipment b Use correct a Use Task A: Clean environment amounts of appropriate agent cleaning agent c Download d Monitor Task B: Perform clean in b Set manual e Close clean a Obtain SOP automated sequence in place valves system sequence process c Download e Steam system f Cool to room Task C: Perform steam in b Set manual d Pressure test g Shut down a Obtain SOP automated at appropriate temp with air place valves Vessel system sequence temperature pressure d Ensure for Task D: Autoclave materials a Clean material b Wrap material c Load autoclave passing run Task E: Depyrogenate d Ensure for a Clean material b Wrap material c Load Depyro material passing run Task F: Wash glassware and a Soak b Rinse d Label e Store c Dry equipment small equipment equipment equipment equipment equipment 4. Pack Columns a Obtain and b Install frits and Task A: Assemble column soak new frits O-rings to flow body and O-rings adapters b Rinse column a Soak column Task B: Sanitize column body until cleaning body in caustic solution removed a Add slurry b Shake c Pour into Task C: Slurry resin buffer to desired vigorously column body ratio c Lower top flow Task D: Pack resin to a Flow buffer to d Measure bed e Calculate b Remove air adapter to resin specifications specification height column volume surface a Test column b Calculate c Clean resin for d Sample for efficiency HETP and preparation for prepared column Task E: Prepare column for asymmetry use as required process use

JOB FUNCTIONS COMPETENCIES

5. Perform Protein

Purification d Prepare tanks Task A: Receive product from a Initiate transfer e Sample and b Mix product c Sample product and equipment upstream processing sequence test product for process steps b Equilibrate a Clean column Task B: Perform column with c Load column d Elute product e Regenerate with appropriate chromatography steps appropriate with product from column column buffer buffer e Integrity test Task C: Filter product as a Pressurize b Assemble filter c Bleed air from d Monitor filter once necessary holding tank train filter transfer transfer complete a Assemble Task D: Perform UF/DF and c Integrity test d Concentrate e Exchange f Integrity test g Insert filter h Run test filters into UF b Clean skid viral removal steps filters product buffer filters into house program skids a Sterilize final c Pool final e Transfer for Task E: Bulk fill purified b Clean room d Integrity test product product into final further product and BSC/LFA filter containers containers processing c Communicate d Use data b Identify instances of a Respond to management Task F: Troubleshoot process abnormal abnormality to alarms systems to conditions subject matter identify trends experts a Remove d Prepare f Deliver sample c Aliquot sample Task G: Sample and manage volume needed b Standardize solutions as for testing or to h Discard unused to appropriate e Analyze results g Record results process testing for test from test equipment necessary for appropriate sample quantity containers vessel particular test location a Operate d Use IT b Download c Run data e Operate quality Task H: Operate and use methods for platforms CIP/SIP systems for batch systems (LIMS, control systems chroma-tography required for sequences reporting change control) steps business systems

Knowledge, Skills, and Equipment Manufacturing Technician (Downstream)

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Clean Room Experience Chromatography Skid B – Basic I – Intermediate A – Advanced Communication Clamps Computer Applications Columns Key to Type of Knowledge/Skill Required: Documentation Conductivity Meters C – Conceptual P – Practical/Applied Ergonomics Flexhoses GMP Flowmeter Handle Audit Gaskets Level IndustrialType Safety Integrity Testers Mechanical Peristaltic Pumps Biochemistry ...... B OrganizationalC pH Meters Chemistry ...... B ProblemC Solving Pressure Gauges Computer Science ...... I TimeP Management Process Tanks Electronics ...... B P Scales Math ...... B P UF Skid Mechanical Engineering...... I P UV Spectrophotometer Microbiology...... B C Plumbing ...... I P Technical Writing ...... I P

Job Functions, Tasks, and Competencies of INSTRUMENTATION/CALIBRATION TECHNICIAN Maintains, calibrates, tests, troubleshoots, and repairs circuits, components, analytical equipment, and instrumentation. Performs validation studies. Requests purchase of components.

JOB FUNCTIONS COMPETENCIES 1. Perform Calibration b Use a Use PC skills communication Task A: Schedule instrument to generate skills to schedule calibration with end use calibration work calibration order activity with end users a Read and use b Apply concepts Task B: Read SOP SOPs to work process b Demonstrate c Follow safety a Use standards appropriate Task C: Gather necessary procedures and and required mechanical tools regulations when equipment aptitude when working using tools a Use b Use documentation Task D: Note as-found appropriate tools skills to record conditions of instrument to be to remove the how the calibrated instrument to be instrument is calibrated installed c Use analytical e Perform math/ a Use b Use electrical skills to evaluate calculations g Practice mechanical skills skills when data from comparison to fundamentals of d Work safely; f Use scientific to attach and attaching related calibration determine the temperature, h Practice follow safety calculator to operate electrical reference error of the pressure, flow, measured values Task E: Perform calibration procedures and perform calibration calibration standard instrument being weight, speed, and regulations when calculations and reference reference equipment and calibrated from time, pH, and/or units/conversions working comparisons standard standard compare it to the reference resistivity/ equipment equipment instrument being standard conductivity calibrated equipment b Use a Use PC skills documentation Task F: Document and notify to notify skills to appropriate people of the appropriate document results persons completion of calibration

JOB FUNCTIONS COMPETENCIES b Use a Use c Work safely; mechanical appropriate tools follow safety Task G: Return to as-found aptitude to attach to return procedures and condition and return instrument to regulations when instrument to original state working original state a Demonstrate math skills to verify math b Use standard Task H: Review calculations documentation documentation performed process during calibration Task I: Enter findings in a Use PC skills database; update and retrieve to enter data data from database 2. Perform Documentation a Use PC skills to generate b Use Task A: Generate calibration report (e.g., Blue appropriate report Mountain, documentation

Maximo, skills Datastream) a Use PC skills to generate b Use Task B: Document as-found report (e.g., Blue appropriate data Mountain, documentation Maximo, skills Datastream) a Use PC skills to generate b Use Task C: Document as-left report (e.g., Blue appropriate data Mountain, documentation Maximo, skills Datastream) a Use Task D: Label instrument appropriate when complete documentation skills a Use Task E: Document change or appropriate out-of-tolerance condition documentation skills

JOB FUNCTIONS COMPETENCIES a Demonstrate math skills to verify math b Use standard Task F: Review document calculations documentation performed skills during calibration 3. Troubleshoot Instrument

Failure Task A: Obtain work order a Complete work from end user or work-group order according coordinator to procedures c Use mechanical and Task B: Schedule work for b Use technical skills troubleshooting instrument a Use PC skills communication required for that failed skills general troubleshooting a Collect c Work safely; necessary tools b Demonstrate follow safety Task C: Gather tools and reference mechanical procedures and standard aptitude regulations when equipment working c Use analytical e Perform math/ b Use electrical a Use skills to evaluate calculations/ f Practice skills when mechanical data from the comparison to fundamentals of attaching related d Work safely; Task D: Repair, replace, aptitudes to calibration determine the temperature, g Practice electrical meters follow safety and/or purchase a new adjust or reference error of the pressure, flow, measured values and/or procedures and instrument to replace the determine standard instrument being weight, speed, and units/ calibration regulations when failed instrument appropriate equipment and calibrated from time, pH, and/or conversions reference working replacement compare it to the the reference resistance/ standard instrument instrument being standard conductivity. equipment calibrated equipment b Perform a Use PC skills required to generate documentation to report (e.g., Blue Task E: Log and close out enter work Mountain, preformed in Maximo, appropriate work Datastream) order a Use b Use PC skills communication to notify end user skills to notify and/or others of Task F: Return to owner end user of work work completion completion and results

JOB FUNCTIONS COMPETENCIES 4. Coordinate Calibration

Activities a Use communication b Demonstrate skills to schedule Task A: Schedule instruments consistent instrument and to be calibrated by the time required times equipment that they become due associated with may be calibrations interrupted due to calibration Task B: Notify end user prior b Communicate to performing instrument information to calibration others a Use PC skills to notify end b Communicate Task C: Notify end user after user to information to calibration completion completed others calibration Task D: Notify user of non- a Use standard conformance and/or out-of- procedures for tolerance notification b Cross off a Use instruments that Task E: Communicate within communication have been work group about completed skills to notify completed to calibration to avoid others within notify others duplicating work work group within work group 5. Use Computer for

Various Technical Work Task A: Write/revise c Use MS a Use MS Word b Use MS Excel documents Access b Use Operator a Use Interface e Use HART or c Use BMS Programmable Terminal and/or d Use equivalent (building Task B: Program parameters Logic Controller Human Machine Distributed protocol for management programming Interface Control Systems programming system) software programming instruments software Task C: Use company/ a Use new b Use general PC proprietary software packages software database skills 6. Understand cGMPs a Use Task A: Practice good appropriate documentation documentation skills

JOB FUNCTIONS COMPETENCIES c Use b Use communication a Use PC skills documentation skills to notify Task B: Attend training to to attend online skills to record others within support cGMPs training courses training work group of completed training completed

Knowledge, Skills, and Equipment Instrumentation/Calibration Technician

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Key to Knowledge/Skill Level Required: Calibration Standards Traceable to NIST B – Basic I – Intermediate A – Advanced B – Basic I – Intermediate A – Advanced (Pressure/Temperature Flow)

Key to Type of Knowledge/Skill Required Key to Type of Knowledge/Skill Required Amp Meters C – Conceptual P – Practical/Applied C – Conceptual P – Practical/Applied Decade Box Level Type Fluke Multimeters Level Type Level FlukeType Process Calibrators Frequency Generator Algebra 1 & 2 ...... B BasicP Electricity and Electronics ...... I Hart PCommunicators (Smart Communications) Chemistry ...... B BasicC Plumbing and Piping ...... I SolderingP Equipment/Materials Computer Science Computer Applications ...... A P (Automation and GMP ...... A P Programming) ...... I TechnicalP Writing ...... A P English ...... B P Physics ...... B Calibration/InstrumentationP Specific Training  Analytical (pH, Conductivity and Resistivity, DO2, TOC)  Control Valves  Flow Liquid and Mass Flow  Level (Transmitters, Load Cells, Differential, Radar, Sonar, Float Type, Capacitance)  Limit Switches  Pressure Calibration (Transmitters, Switches, Gauges, Differential, Vacuum, I/P)  Profibus/Fieldbus (Digital Technology)  Rotational (Pumps, Motors, VFD, Agitators)  RS LOGIX  Temperature (Thermocouples, RTD’s, BiMetallic Thermometers, Glass Thermometers, Transmitters, Chambers)  Time (Timers, Stopwatches)  Weight/Mass (Balances And Scales)

Job Functions, Tasks, and Competencies of CHEMISTRY QC TECHNICIAN Tests samples for internal and external customers; analyzes, communicates results; reviews, validates, troubleshoots procedures; monitors environment, equipment, instrumentation

JOB FUNCTIONS COMPETENCIES 1. Test Samples a Identify sample; b Remove sample c Label sample d Store according to Task A: Collect sample inspect all sample with proper properly specifications parameters technique a Use familiarity b Look up in product Task B: Determine appropriate testing with tests performed SOP to determine in the lab testing c Fill out appropriate d Use conductivity f Review post- Task C: Prepare reagents a Use balance b Use pH meter e Use filter/degas paperwork meter preparation b Acquire all a Read procedure for Task D: Review testing procedures necessary materials clarity and equipment a Set up labeled c Dilute schemes Task E: Execute testing b Perform pipetting tubes with many variables a Correct and b Look for aberrant c Determine assay Task F: Analyze data interpret results results validity a Report results Task G: Evaluate data with regard to b Compare result to using appropriate specification acceptance criteria medium b Initiate deviation/ c If accept, follow a If reject, follow Task H: Accept or reject data out-of-specification/ procedure to hand off applicable procedure discrepancy report results to next group a Evaluate data with b Follow applicable Task I: Monitor data trending regard to historical procedure for out-of- results trend results 2. Provide Customer Service (Internal) c Give scientific a Provide input on b Coordinate stat Task A: Consult with appropriate department background for scheduling samples situations a Determine b Identify correct test appropriate Task B: Determine necessary testing to monitor each department for parameter testing a Communicate results using Task C: Report result to appropriate appropriate system departments (paper, electronic, verbal) a Discuss which tests c Define corrective Task D: Troubleshoot aberrant results or b Review data to to run to eliminate actions/preventive parameters identify cause causes actions

JOB FUNCTIONS COMPETENCIES 3. Control Documentation a Research procedure b Follow QA format c Technically write d Ensure clarity and Task A: Write SOPs or product for SOPs outline for procedure readability a Conduct peer/ c Ensure b Check for SOP department review responsibilities can Task B: Review SOPs clarity and using knowledge of be met by department conciseness SOPs receiving SOPs a Review peer assay b Archive data in Task C: Review data data for accuracy and appropriate location GMP compliance b Ensure QC Task D: Review manufacturing a Check for accuracy sampling plan is documentation of material content correct a Know how to d Execute corrective technically write b Generate data in c Fill out all Task E: Capture investigations/ deviations action/preventive investigation/ report format appropriate forms action deviation c Use appropriate a Make reports b Follow acceptable Task F: Write technical reports software to defend legible and clear SOP for format conclusion a Complete daily d Document b Review peer c Compile and Task G: Maintain notebooks/ logbooks entries in GMP maintenance and out notebooks archive periodically manner properly of service a Record daily b Record time for Task H: Document routine activities calibration/ applicable cost codes standardizations b Perform any a Give input of c Justify changes to Task I: Participate in change control activities changes to document process changes QA approved system a Compile and organize data, assay Task J: Archive documents/data forms, and other documents 4. Monitor Environmental Parameters a Perform chemical b Ensure within Task A: Monitor water quality tests on water specifications for samples water quality a Conduct daily check to ensure b Call for service c Troubleshoot when Task B: Monitor controlled equipment equipment operation when necessary necessary in spec a Check temperature on controlled areas Task C: Maintain environmental logs

JOB FUNCTIONS COMPETENCIES 5. Obtain and Maintain Permits b Educate yourself c Document Task A: Maintain awareness of permits of a Identify controlled on rules of necessary necessary controlled substances substances in lab permits information 6. Educate Employees a Coordinate training b Schedule time for Task A: Facilitate new employee training tasks Q&A about assay b Review new c Customize for a Ensure new d Identify needed Task B: Follow approved curriculum for employee curriculum specific employee employees attend all assays for highest training for additions or based on skills and required trainings priority training omissions background a Observe new b Review results and c Give feedback for Task C: Train employees in job-specific tasks analyst performing procedures improvement tests a Document in b Store records in c Know how to Task D: Maintain training records compliant manner accessible location document training b Use internal a Supplement employees, vendors, Task E: Identify additional training needs training with institutions, and (e.g., outside resources) seminars/courses consulting firms as provided by experts “experts” 7. Comply with Regulations b Recognize that a Follow carefully all results not valid if Task A: Follow all written procedures exactly controlled documents established and procedures procedure not followed a Research better Task B: Keep up on industry alternative testing regulations/literature methods a Maintain awareness Task C: Review documentation for regulatory of changes in compliance regulations c Answer questions a Use of both internal b Ensure compliance concisely, without Task D: Participate in regulatory audits and external audits on all procedures extraneous information 8. Provide Technical Support a Perform initial b Work with c Troubleshoot in correlation studies to d Identify approved e Document protocol Task A: Transfer new technology/assays customers to validate instances where there determine acceptable alternative vendors and final report new process/assays is non-comparability parameters b Explain uses of c Ensure explanation Task B: Instruct an optimum use (product, a Identify customer product or is adequate to meet instrumentation, systems) requirements instrumentation to needs through meet needs communication Copyright © 2006 Northeast Biomanufacturing Center Page 29

JOB FUNCTIONS COMPETENCIES b Provide trainings a Give appropriate that encompass Task C: Provide technical training to trainings to meet scientific theory, customer (internal and external) customer needs history, and background a Identify test b Investigate any Task D: Troubleshoot at request of customer methods needed to possible root cause be run of differences a Use knowledge/skills to b Accompany Task E: Interact with vendors get vendors to work vendors while at site with you 9. Perform and Support Validation a Identify necessary b Identify acceptance d Obtain needed c Write protocol and Task A: Develop validation procedures parameters to criteria for approval for validation plan measure parameters validation plan a Perform needed Task B: Execute validation procedures studies b Capture and c Obtain necessary a Write validation explain any approval for Task C: Defend validation results report discrepancies to validation report to validation plan implement change b Perform any test requested by c Develop or a Support manufacturing purchase other tests Task D: Test manufacturing validation manufacturing regularly run by the at the request of samples validation efforts lab (sterility, pH, manufacturing not through testing protein currently supported concentration) 10. Maintain Systems and Equipment a Create/write PM Task A: Perform preventive maintenance b Order any required c Perform d Review peer schedule and (PM) parts maintenance maintenance protocol e Obtain review of d Generate out-of- a Create/write calibration; f Document that c Use document tolerance/ Task B: Perform instrument calibrations calibration schedule b Perform calibration create/write PM calibration was results discrepancy when and protocol schedule and performed necessary protocol b Ensure d Document that a Coordinate with c Review vendor Task C: Schedule vendor maintenance maintenance meets maintenance was vendor maintenance lab schedule performed a Identify potential b Determine causes for failure products/results Task D: Troubleshoot equipment failures affected by failure

JOB FUNCTIONS COMPETENCIES 11. Conform to Health and Safety

Procedures a Wear gloves, Task A: Wear proper personal protective goggles, aprons, and equipment respirator, as needed a Read and follow b Attend safety Task B: Follow lab safety procedures approved procedures orientation a Maintain awareness b Avoid standing at Task C: Maintain awareness of correct of repetitive motion hood for long periods ergonomic positions and activities problems, especially of time pipetting a Know where b Be familiar with Task D: Maintain familiarity with MSDSs MSDSs are located chemical labels a Practice proper use b Perform all Task E: Use hoods where appropriate of chemicals and reactions that emit procedures fumes in the hood a Know that sharps Dispose of broken c Ensure correct Task F: Dispose of sharps properly are to be discarded in glass in appropriate labeling on all waste appropriate container container containers b Report all incidents a Follow safety Task G: Complete accident reports at time of to supervisor and on guidelines and occurrence official form procedures immediately 12. Comply with Environmental

Regulations b Maintain familiarity with c Dispose of Task A: Dispose of hazardous and chemical a Identify hazardous disposal regulations materials in properly waste properly materials within lab and guidelines set labeled containers forth by EHS 13. Manage People c Put into place a Assess employee’s b Identify future Task A: Determine employee development proper training and d Periodically review current abilities and goals through plan opportunities to development plan skills discussions achieve goals d Be aware of a Regularly assess b Ensure work is c Promote teamwork activities and Task B: Monitor employee work load and employee stress and spread correctly through action and logistics involved in stress level workload, and across lab leadership assays/data communicate to team analysis/review b Follow procedures Task C: Perform peer/management period a Perform period for adequate/ reviews reviews approved documentation a Identify resources Task D: Participate in recruitment process needed within the lab

JOB FUNCTIONS COMPETENCIES a Demonstrate c Use effective d Work to reduce leadership and communication b Remedy problems office gossip/ Task E: Develop positive staff morale interaction; skills, identifying as they occur unprofessional encourage positive specific personal behavior morale issues

Knowledge, Skills, and Equipment Chemistry QC Technician

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Aseptic Technique (Gowning; Laminar Flow Hoods; BSCs) AIEF NIR B – Basic I – Intermediate A – Advanced Corrective and Preventive Action Analytical/Guard Columns NMR GMPs Autoclave Nutrient Meter (dO, NH3, Key to Type of Knowledge/Skill Required: Office Equipment Operation Autotitrator dCO) C – Conceptual P – Practical/Applied Plant or Material Flow (Dirty/Clean) Balance Osmometer Technical Reading and Writing Level Type Centrifuge Ph Meter Time Management Coagulation Analyzer Pipettors Algebra ...... B C Concentrators Plate Reader Biology ...... B C Conductivity Meter Plate Shaker Business Management Degasser Plate Washer (Basics; Budget; Cost-Benefit Densitometer Plate Washer For Beads Analysis Economics) ...... I P De-salting Columns Printers Computer Skills and Dialysis Cassettes/Tubes Purification Fraction English...... A P Electrochemical Detectors Collector Logic/Critical Thinking/Cause FTIR Refrigerator/Freezer Analysis ...... B C Fume Hood SDS-Page (Poured And Pre Microcomputer Applications Gamma Counter Cast) (MS Office) ...... I P GC Shaker/Incubator Regulatory Affairs ...... B C Gel Dry System Sparge System Social Science (Ethics, Psychology, Turbidity Meter Spectrophoter Sociology) ...... I P Gel Power Packs Test Tube Racks Statistics ...... B C Glucose/Glutamine Meter Vacuum Centrifuge Technical Writing ...... B P Heat Block Vacuum Pump Hot Stir Plate Volumetric Pipettes And HPLC Flasks Hydrometer Vortexer IEF Water Bath IEP Tanks Wrenches Immunodiffusion Plates Immunodiffusion Viewer Incubator Ion Chromatography Mass Spec

Job Functions, Tasks, and Competencies of MICROBIOLOGY QC TECHNICIAN Performs routine microbiological testing of raw materials, in-process samples, and finished products. Monitors manufacturing areas, equipment, and processes. Calibrates and maintains equipment.

JOB FUNCTIONS COMPETENCIES 1. Perform Testing Task A: Monitor environmental a Sample total air b Sample viable air c Test surface conditions particulates particulates cleanliness b Perform staining c Perform biochemical d Utilize identification Task B: Identify microbial a Isolate colonies techniques (e.g., Gram tests (e.g., Catalase systems (e.g., Midi, e Use selective media growth stain) test) Vitek) b Use endotoxin Task C: Test for endotoxin (e.g., a Use gel clot or detection systems (e.g., water, in-process, final product) kinetic method Endoscan) b Use membrane Task D: Test for bioburden (e.g., filtration (i.e., Nalgene a Use spread plates c Use pour plates water, in-process, final product) filters or Milliflex system) Task E: Test with biological a Use ampoules b Use spore strips indicators Task F: Test for quality of a Perform growth b Perform population media/reagents promotion recovery testing Task G: Perform basic a Streak/isolate on d Conduct reagent b Use pipettes c Perform ascetically microbiology lab techniques media preparation b Use surface sampling Task H: Monitor personnel a Use touch plates plates (e.g., RODAC plates) b Transfer developed Task I: Transfer a Transfer customer technologies across methods/technologies methods/ technologies company sites a Ensure compliance c Search for and fix Task J: Review data b Verify calculations with SOPs errors 2. Provide Customer Service b Communicate results Task A: Work with internal a Coordinate sampling and information to customers with other departments departments b Communicate with Task B: Work with external a Communicate with contract manufacturing customers vendors sites/personnel 3. Conduct Documentation a Develop Task A: Author documents b Write SOPs methods/forms a Track/ reconcile b Track official copies Task B: Control documents assay data sheets of SOPs/ forms

JOB FUNCTIONS COMPETENCIES Task C: Maintain training a Read and understand records current SOPs e Acquire and become a Enter data accurately c Record appropriate familiar with the Code Task D: Check for cGMP b Use control data on paperwork and in reference numbers in d Review data of Federal Regulations compliance sheets computer log book (CFR) and other regulatory information b Maintain list of c Generate periodic a Enter assay data into Task E: Conduct electronic samples to verify test reports according to computer database documentation completion and to track department needs (i.e., (i.e., LIMS) samples received quarterly reports) 4. Manage Information a Accurately record b Prepare assay raw data on environmental Task A: Obtain/report data paperwork; enter data action/excursion in computer follow-up reports b Prepare reports of a Analyze data from data (e.g., trend reports, Task B: Trend/benchmark data testing results quarterly identification reports Task C: Review data a Review report b Search for trends 5. Conduct Training a Instruct people to d Make sure people can Task A: Train people to follow b Instruct people to c Observe people read procedure perform the procedure SOPs observe procedure performing procedure documentation independently Task B: Train people on in-house a Use aseptic b Use gowning protocols techniques techniques 6. Provide Technical Support b Write memos or Task A: Assist with process a Track information or technical information investigations locate information bulletins 7. Perform/ Support Validation a Write instrument qualifications or b Perform assays for Task A: Validate methods performance qualification qualifications a Write instrument qualifications or b Perform assays for Task B: Validate equipment performance qualifications qualifications 8. Conduct Maintenance Task A: Troubleshoot a Perform routine b Perform corrective c Maintain instruments maintenance maintenance maintenance records

JOB FUNCTIONS COMPETENCIES b Conduct Task B: Monitor equipment a Monitor temperature environmental performance charts daily monitoring of lab BSCs b Check expiration c Perform routine Task C: Maintain laboratory a Wrap/prepare items dates of reagents, d Order reagents/media cleaning (i.e., BSC, space for autoclaving media, equipment (i.e., inventory control) incubator, bench tops) calibration dates 9. Follow Health/ Safety

Procedures a Dispose of b Dispose of sharps Task A: Dispose of waste biohazardous wastes according to protocols according to protocol b Wear lab coat Task B: Use routine lab safety c Read MSDS reports f Follow lab safety a Wear safety glasses properly (e.g., d Wear long pants e Tie back long hair precautions for lab chemicals, etc. protocols buttoned)

Knowledge, Skills, and Equipment Microbiology QC Technician

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Key to Knowledge/Skill Level Required: Anaerobic Chamber B – Basic I – Intermediate A – Advanced B – Basic I – Intermediate A – Advanced Autoclave Biology Key to Type of Knowledge/Skill Required: Key to Type of Knowledge/Skill Required: BSCs C – Conceptual P – Practical/Applied C – Conceptual P – Practical/Applied Centrifuges Colorimeters Type Level Fluorescent Microscope Algebra ...... Aseptic... B Technique (Gowning; Laminar Freezers Biochemistry ...... FlowB Hoods; BSCs) ...... Fume P hood Biology ...... Autoclave.... I Theory/Practice ...... Heating C Blocks Cell And Molecular Biology ...... Chemical.. B Handling...... ID P Systems: Vitek, API, MIDI Chemistry ...... Corrective B and Preventive Action ...... Incubators C Computer Skills/Microcomputer GLPs ...... Kinetic. C -chromatogenic Plate Reader For Endotoxin Testing Applications (MS Office) ...... GMPs... B ...... Label P maker Diagnostic Microbiology ...... Instrumentation B (Process Controls Leader 50 (for Mycoplasma Detection) English ...... andB Calibration) ...... LIMS P Immunology ...... Pharmaceutical B Grade Waters (WFI; Water Manual and Electronic Pipettes Logic/Critical Thinking/Cause Analysis ...... PreB -Treatment; Reverse Osmosis, DI) ...... Media C Microbiology ...... Plant A or Material Flow (Dirty/Clean) ...... Microscopes C/P Regulatory Affairs ...... Technical B Reading and Writing ...... MicroStar P Social Science (Ethics, Psychology, Time Management ...... Milliflex C Bioburden System Sociology) ...... B Pipet Aids Statistics ...... B Plate readers Technical Writing ...... B Refrigerators Virology ...... B Scan RDI Total Particulate Monitors (Met One, CliMet, ) Viable Particulate Monitors (RCS, RCS Plus, M-Air-T) Vortexes Water Baths

Job Functions, Tasks, and Competencies of ENVIRONMENTAL HEALTH AND SAFETY TECHNICIAN Monitors water and air; calibrates and maintains scientific monitoring equipment and performs routine analysis of all environmental and monitoring systems; processes permits

JOB FUNCTIONS COMPETENCIES 1. Pursue Professional Credentials b Use first aid/AED c Maintain OSHA-related a Maintain OSHA site emergency Task A: Maintain certifications (automatic external professional organization operations standard (HazWoper) defibrillator)/CPR certifications e Comply with ATF d Comply with NFPA Task B: Comply with pertinent c Comply with state/local (Bureau of Alcohol, a Comply with OSHA b Comply with EPA/FDA (National Fire Protection regulations regulations Tobacco, and Firearms) Association) regulations Task C: Attend job-related industry b Attend ASIH (American c Keep updated about d Make use of adult a Attend ASSE (American Society events and professional development Society of Industrial other professional learning and teaching of Safety Engineers) events courses Hygienists) events organizations skills Task D: Be proficient with pertinent a Use MS Word b Use MS Powerpoint c Use MS Excel d Use MS Access e Use MS Projects software programs 2. Maintain Documentation Task A: Maintain records (e.g., pest b Apply knowledge of a Apply knowledge of MS Excel d Use technical writing control, wastewater, waste manifests, regulatory requirements c Use filing techniques and MS Access skills air, SPCC, RCRA, safety-OSHA) for specific records Task B: Collect data (e.g., pest b Apply knowledge of a Apply knowledge of MS Excel d Use technical writing control, wastewater, waste manifests, regulatory requirements c Use filing techniques and MS Access skills air, SPCC, RCRA, safety-OSHA) for specific records Task C: Track data (e.g., pest b Apply knowledge of a Apply knowledge of MS Excel d Use technical writing control, wastewater, waste manifests, regulatory requirements c Use filing techniques and MS Access skills air, SPCC, RCRA, safety-OSHA) for specific records a Make use of technical writing Task D: Prepare and maintain SOPs b Use MS Word c Use subject knowledge skills 3. Train Personnel b Teach how to use c Explain the specifics of Task A: Conduct new hire a Teach new employees the personal protection the site emergency action orientation community right-to-know standard equipment (PPE) plan requirements Task B: Provide safety training a Apply knowledge of 29 CFR b Use adult learning and c Train people on site

(according to 29 CFR 1910) 1910 (OSHA) teaching skills emergency action plans b Provide knowledge of c Provide knowledge of a Provide knowledge of hazardous medical waste (e.g., Task C: Provide environmental SCCP (spill control waste classifications, labeling, and handling, storage, training contingency plan) (e.g., waste streams (RCRA) transportation, disposal, storm water control) classification) Task D: Conduct contractor safety a Provide knowledge of OSHA training construction safety regulations

JOB FUNCTIONS COMPETENCIES a Provide knowledge of back b Provide knowledge of c Provide knowledge of d Provide knowledge of Task E: Provide health training safety, lifting, and back mechanics ergonomics industrial hygiene respiratory protection 4. Comply with regulations Task A: Create plans (i.e., be able to a Use knowledge of pertinent b Use technical writing c Use MS Word/MS Excel use pertinent regulations) regulations skills a Prepare periodic reports as Task B: Maintain permits and plans c Use technical writing d Use MS Word/MS required by regulations or b Use negotiating skills (e.g., air, water, waste) skills Excel circumstances 5. Provide Technical/Customer

Support e Use safety equipment Task A: Conduct job hazard a Use knowledge of safety b Use technical writing c Use communication d Use diplomacy skills according to function and assessment (JHA) committees, cultures, and theories skills skills purpose c Communicate d Use diplomacy skills Task B: Perform environmental a Use appropriate auditing b Use technical writing information to appropriate when communicating to health and safety audits techniques skills people people 6. Address Health Issues in

Workplace e Make use of American b Apply knowledge of c Use knowledge of d Use knowledge of Conference of Task A: Conduct industrial hygiene a Use knowledge of monitoring methods of collection and indoor air quality Material Safety Data Governmental Industrial monitoring equipment proper medium to use for standards Sheets (MSDS) Hygienists (ACGIH) collection standards Task B: Maintain auditory protection b Use knowledge of a Use knowledge of equipment program auditory functions Task C: Maintain respiratory b Use knowledge of c Apply knowledge of fit a Use knowledge of equipment program respiratory functions testing c Maintain automatic a Maintain basic first aid b Maintain CPR Task D: Maintain first aid team external defibrillator certification certification certification 7. Address Safety Issues in

Workplace a Interview parties, access damage, Task A: Investigate accidents; use b Apply methods of c Conduct a root-cause d Determine corrective/ secure scene, take samples, and investigative skills critical thinking analysis preventive action reconstruct incident b Provide literature about Task B: Provide safety training a Hold workshops for personnel safety issues Task C: Coordinate worker a Communicate specific required compensation issues knowledge to workers 8. Manage Information c Use MS Word/ d Use public speaking Task A: Provide reports and a Use knowledge of statistical b Use technical writing MS Excel/ skills to provide feedback methods skills MS Powerpoint information

Knowledge, Skills, and Equipment Environmental Health and Safety Technician

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Key to Knowledge/Skill Level Required: Industrial Hygiene Monitoring Equipment B – Basic I – Intermediate A – Advanced B – Basic I – Intermediate A – Advanced Four-Gas Monitor Audiometer Key to Type of Knowledge/Skill Required: Key to Type of Knowledge/Skill Required: Safety Shower Test Equipment C – Conceptual P – Practical/Applied C – Conceptual P – Practical/Applied Fall Protection Equipment Level Type Safety Glasses/Goggles Level Type Chemical Apron Algebra ...... I AsepticP Technique (Gowning; Laminar Sleeve Protectors Anatomy and Physiology ...... B CFlow Hoods; BSCs) ...... B Face ShieldP Biology ...... B BoilersP ...... B RespiratorC Business Management (Basics; Chemical Handling...... A Steel ToeP Shoes Budget; Cost-Benefit Corrective and Preventive Action ...... A Hard HatsP Analysis Economics) ...... B Electricity/ElectronicsC ...... B HearingC Protection Chemistry ...... I FallP Prevention (Heights) ...... A Hand PTruck Computer Skills and GMPs ...... B pH metersC Microcomputer Applications HVAC ...... B ConductivityC Meters (MS Office) ...... I LockP -Out/Tag-Out (LOTO) ...... A MedicalP Oxygen Earth Sciences ...... B MobileP Elevated Work Platforms ...... A AEDsP Engineering (Environmental) ...... B OfficeC Equipment Operation ...... B Drum PDolly English...... I PlantP or Material Flow (Dirty/Clean) ...... B ISCO PSampler Environmental Law ...... I PoweredC Industrial Vehicles ...... A Air EmissionP Monitoring Equipment Environmental Science ...... A PressureP Safety (Increasingly Confined Space Rescue Equipment Health Science/Industrial Hygiene ...... A PImportant) ...... A SCBAP Logic/Critical Thinking/Cause Pumps ...... B Spill responseC Equipment Analysis ...... B RiskC Assessment ...... A Fire ExtinguishersP Microbiology ...... B TechnicalC Reading and Writing ...... A HVACP Vacs (Explosion Proof) Organic Chemistry ...... B TimeP Management ...... B Drum PPumps Physics...... B WasteC Water Treatment ...... A Fire Suppression/AlarmP Systems Regulatory Affairs ...... A P Social Science (Ethics, Psychology, Sociology) ...... B C Statistics ...... I P Technical Writing ...... A P Toxicology ...... B C

Job Functions, Tasks, and Competencies of QA DOCUMENTATION COORDINATOR Provides administrative support related to documentation systems. Audits all documentation manuals to assure accuracy, timelines, availability. Maintains and archives all master documents.

JOB FUNCTIONS COMPETENCIES 1. Provide Customer

Services e Learn about a Display d Use task company culture, Task A: Evaluate others’ b Use planning c Use time f Manage g Use h Be realistic understanding of analysis skills to objectives, goals, priorities and rank their skills (e.g., management projects to meet communication about what you deadlines and determine structure in order urgency scheduling) skills deadlines skills can achieve other priorities priorities to understand big picture e Learn about a Define issues c Dig for facts to company culture, b Demonstrate d Use Task B: Troubleshoot/ clearly to your understand full objectives, goals, familiarity with diplomacy/ negotiate clients and your picture and structure; issues people skills manager respond correctly understand big picture e Assess c Develop lesson a Teach classes d Record that training; modify b Provide one- plans (write Task C: Train customers (e.g., revisions of training was if necessary; on-one training materials, create SOPs) done provide presentations) retraining b Provide Task D: Provide technical a Respond to c Use database knowledge on support questions skills system subject a Provide b Use knowledge Task E: Provide electronic customers with of system to copies of SOPs e-copies meet needs a Implement b Use task Task F: Provide weekly list of knowledge of c Use e-mail management document changes system/subject system skills matter, etc. Task G: Maintain smooth b Attend a Use people interdepartmental meetings with skills relationships customers a Acquire and b Demonstrate c Communicate develop speaking knowledge of departmental Task H: Communicate skills system/subject philosophy department’s policies, matter, etc. schedules, and priorities to other departments

JOB FUNCTIONS COMPETENCIES 2. Manage Documentation/

Information and Records b Be able to proofread/edit e Communicate a Use computer documents, using c Pay attention to d Manage work with change f Know and Task A: Process documents skills common detail flow agents/ follow deadlines proofreading approvers, etc. marks Task B: Archive, retrieve, a Follow c Meet and b Maintain determine retention, authorize procedures/ understand orderly system destruction of records policies deadlines c Know about, follow company e Learn and use b Train new d Learn and use Task C: Control official culture, goals, audit skills/ a Follow SOPs administrators/ database/ documentation structure in order knowledge to users computer skills to understand big audit documents picture c Learn and use d Read a Pay attention to f Display math skills (sig documentation detail (such as e Use time flexibility in Task D: Issue and review b Proofread figs, etc.) to and attend math management responding to batch records documents verify training to calculations, all skills shifting work calculations, understand blocks filled in) loads formulas, etc. process d Use judgment a Learn and skills to ensure Task E: Review incoming understand other c Follow Pay attention to proper materials for accuracy and departments’ procedures/ detail attachments, compliance procedures, as policies signatures, etc., well as own are there Task F: Create and maintain b Follow SOP official document books; c Negotiate a Use database for creating and d Provide provide training copies of delivery, skills maintaining customer service documents; conduct periodic creation, content document books reviews a Follow SOP b Practice c Present packets Task G: Issue part numbers; procedures for organization to reviewers and create packet for materials creating part skills approvers management numbers a Guide work b Maintain c Exercise Task H: Facilitate document flow by awareness of understanding of approvals negotiating deadlines approval process timelines a Use database b Use computer c Follow Task I: Enter data into skills to enter skills to retrieve procedures databases and spreadsheets for data to create data and monitor tracking/trending purposes reports (e.g., trends Excel)

JOB FUNCTIONS COMPETENCIES b Monitor/ a Develop participate in Task J: Order supplies and familiarity with c Maintain d Anticipate e Follow up with budgeting (some maintain inventories system used to inventory need/demand vendor general order supplies accounting) 3. Train New Employees, Outside Vendors,

Incumbent Workers, Temporary Workers a Develop a b Provide one- Task A: Train customers c Record training lesson plan on-one training b Educate staff e Use c Train and Task B: Train employees and a Train to use about other d Educate and presentation mentor new staff new software departments’ train superiors skills to train colleagues systems new employees b Attend and a Develop a d Learn how to actively c Pursue strong subject- translate GMPs Task C: Train staff on GMPs participate in continued matter to practical outside courses education knowledge applications on GMPs 4. Comply with Regulations b Know and use a Use database both c Develop Task A: Maintain device skills to enter/ documenting and interdepartmenta master files retrieve data manufacturing l relationships process a Maintain Task B: Write policies/ knowledge of b Use writing c Use computer d Use industry procedures in accordance with regulations (read, skills skills standards regulations review, comprehend) c Use diplomacy g Understand b Use e Create and Task C: Perform and support a Pay attention to when dealing d Train in audit and follow communication maintain f Maintain files internal audits detail with people techniques procedures/ skills spreadsheets being audited policies b Know c Know and Task D: Review and approve a Pay attention to d Use computer company’s follow nonconformance reports detail skills processes regulations a Use Task E: Support regulatory d Provide e Use knowledge spreadsheet b Maintain files c Analyze data affairs customer service of regulations database skills c Be attentive to b Follow QA document- Task F: Keep current training regulations/ a Attend training ation revisions to record files procedures/ keep training policies records current a Follow SOPs Task G: Adhere to SOPs for various procedures Copyright © 2006 Northeast Biomanufacturing Center Page 43

JOB FUNCTIONS COMPETENCIES 5. Provide Technical Support to Internal Customers a Use office c Manage work Task A: Process documents equipment and b Use databases flow systems a Use and c Determine Task B: Use and provide b Use data improve purpose of metrics analysis skills database skills metrics Task C: Maintain systems a Maintain d Know and use e Demonstrate c Interact with f Know and use (user accounts, passwords, knowledge of b Follow SOPs software changes communication help desk regulations back-ups) systems (upgrades, etc.) skills Task D: Train on QA doc a Use word b Know and use tools (templates, forms, etc.) processing skills systems a Acquire foreign language Task E: Translate documents skills or use b Use work and process changes computer processing skills translation system a Know and use Task F: Provide style guides English style and usage 6. Manage People b Maintain c Maintain e Approve f Conduct knowledge of knowledge of big d Maintain timesheets, performance a Maintain Task A: Implement HR HR resources picture (i.e., awareness of vacation reviews; g Know labor knowledge of policies (e.g., templates, know what’s corporate requests, medical motivate laws HR policies forms, trainings, coming/future philosophy leaves; make use employees to etc.) corporate goals) of HR resources develop careers a Establish work b Demonstrate c Communicate d Assess skill e Give and goals leadership skills with and know sets (e.g., future f Encourage h Set example of Task B: Manage daily receive g Motivate your staff fit for new development of work ethic for activities constructive employees project, new staff skills staff feedback position, etc.) a Use conflict b Practice c Be assertive d Respond to Task C: Resolve disputes management diplomacy problems skills immediately a Maintain b Utilize HR c Provide career Task D: Promote career knowledge of resources development development; mentor staff career options skills to employees

JOB FUNCTIONS COMPETENCIES a Use b Use listening c Have patience d Be able to communication skills tolerate different skills behavioral styles Task E: Counsel employees

7. Manage Project g Apply Task A: Plan priorities and a Use b Demonstrate d Apply e Interact with knowledge of h Follow c Follow through f Practice events (e.g., define, measure, organizational communication knowledge of big other personal styles/ timelines and to realize goals leadership skills analyze) skills skills picture departments behaviors/skills meet deadlines of the group b Use e Use problem Task B: Troubleshoot a Use negotiation prioritization c Be assertive d Be creative solving, critical f Be flexible problems in work skills skills thinking, etc. 8. Observe Safety Standards a Prepare reports Task A: Prepare workers’ using knowledge compensation incident reports of requirements 9. Maintain Own

Professional Development a Maintain b Attend classes d Complete understanding of that support your c Keep updated Task A: Keep up credentials paperwork for industry professional on literature credentials, etc. standards development b Relate Task B: Read industry a Obtain literature to your literature literature work a Attend d Maintain b Be able to c Work on cross- e Train others on Task C: Learn new systems development understanding of budget as needed functional teams new systems courses industry norms b Use Task D: Develop leadership c Practice a Attend courses presentational skills leadership skills skills a Attend b Practice time c Learn from Task E: Develop time development management others (or trial management skills courses skills and error)

Knowledge, Skills, and Equipment QA Documentation Coordinator

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Key to Knowledge/Skill Level Required: Archiving Boxes B – Basic I – Intermediate A – Advanced B – Basic I – Intermediate A – Advanced Archiving Equipments (Microfilming Cameras, Readers, CDs, etc.) Key to Type of Knowledge/Skill Required: Key to Type of Knowledge/Skill Required: Binders C – Conceptual P – Practical/Applied C – Conceptual P – Practical/Applied Binding Machine Computer Level Type Copier Copy Paper Algebra ...... B C Level CopyType Stamps, Date Stamps, etc Biology ...... B C Database Software (Access, Filemaker Pro, Oracle) Business Management Aseptic Technique (Gowning; Excel (Basics; Budget; Cost-Benefit Laminar Flow Hoods; BSCs) ...... B Fax MachineC Analysis Economics) ...... I CorrectiveP and Preventive File Cabinets (Fire Proof) Computer Skills and Action ...... B Files &C Folders Microcomputer GMPs ...... B HangingC Folders Applications (MS Office) ...... A OfficeP Equipment Operation ...... I Label PMaker English Plant or Material Flow Labels Logic/Critical Thinking/ (Dirty/Clean) ...... B LCD ProjectC or Cause Analysis ...... B TechnicalC Reading and Master Paper Regulatory Affairs ...... B CWriting ...... B MaterialsC Management Software Social Science (Ethics, Time Management ...... I Ms WordP Psychology, Sociology) ...... I P Overhead Projector Statistics ...... B C Powerpoint Technical Writing ...... B C Printer Project Proprietary Software (Document Management Software) Scanner Shredders Staple Removers Three Hole Punch Tools Visio

Job Functions, Tasks, and Competencies of FACILITIES TECHNICIAN Performs daily monitoring, repair, and preventive maintenance activities on critical systems and equipment; troubleshoots, installs, evaluates, and modernizes new and existing systems.

JOB FUNCTIONS COMPETENCIES 1. Conduct Testing Task A: Test boiler water a Test for pH b Conduct testing c Test for phosphate d Know how to test sulfite Task B: Test vessels and systems for a Test for pressure b Conduct hydro test leaks Task C: Test conductivity of RO water a Test pharmaceutical b Sample pharmaceutical

(pharmaceutical waters) waters waters a Test reverse osmosis b Provide water for d Maintain knowledge of e Maintain knowledge of Task D: Test system alarms c Test boiler alarm alarm system injection alarm testing waste treatment alarms Biokill alarm testing Task E: Test filter integrity a Pre-test filters b Post-test filters a Perform static and dynamic tests of pumps, Task F: Test component functionality agitators, seals, motors, flow control valves, etc. 2. Provide Customer Service b Prioritize and schedule c Perform the requested d Follow up on the work Task A: Fulfill work order requests a Receive work order work work you performed 3. Perform Documentation Task A: Perform daily equipment a Conduct readings of air c Take water treatment d Build management b Monitor boiler readings readings compressors and air dryers readings system readings and alarms c Perform all work Task B: Develop, review, revise and a Review SOPs b Revise SOPs according to SOPs and update of SOPs cGMPs. a Ensure operational log paperwork, daily log files, Task C: Use GMPs when working and work order with all documentation documentation is completed with accurate information 4. Obtain and Maintain Permits a Perform a work Task A: Obtain hot work permits b Obtain required approvals assessment a Perform a work Task B: Obtain confined entry permits b Perform air sampling c Obtain required approvals assessment a Perform a work Task C: Obtain excavation permits b Obtain required approvals assessment 5. Provide Training for Employees b Facilitate job shadowing Task A: Provide and support peer a Facilitate job shadowing or training of processes on training for new hires new equipment

JOB FUNCTIONS COMPETENCIES 6. Comply with Regulations a Learn which federal b Perform all jobs Task A: Observe and comply with regulations apply to your according to applicable CFR (Code of Federal Regulations) job, tasks, and industry federal regulations a Learn the cGMPs that Task B: Observe and comply with b Perform all tasks apply to your job, tasks, or cGMPs according to cGMPs industry a Follow all pertinent SOPs Task C: Observe and follow all (may be more than one applicable SOPs SOP per task) 7. Provide Technical Support d Troubleshoot a Perform root cause b Gather and compile Task A: Assist in cause analysis c Perform failure analysis miscellaneous equipment analysis information and systems Task B: Support plant engineering on a Help start-up of new b Evaluate new processes c Fabricate and install new projects equipment and equipment systems and equipment 8. Perform/ Support Validation a Assist with start-up of Task A: Assist with the development new equipment to ensure it and lead in the execution of validation meets all mechanical design documents for mechanical equipment specifications 9. Perform Systems and Equipment

Maintenance Task A: Perform root analysis of a Use critical-thinking, b Use CMMS utility, process and HVAC related brainstorming, and cause- (computerized maintenance equipment/ systems analysis methods management systems) Task B: Perform preventive and c Use CMMS a Use reliability-centered b Adhere to SOPs and corrective maintenance on process (computerized maintenance maintenance cGMPs. systems management systems) Task C: Perform Preventive and c Use CMMS a Use reliability-centered Corrective maintenance of utility b Follow SOPs and cGMPs (computerized maintenance maintenance systems management systems) a Use OEM (original d Use CMMS Task D: Perform component-level b Use of reliability-centered equipment manufacturer) c Follow SOPs and cGMPs (computerized maintenance repairs, rebuilds, and maintenance maintenance practices manuals management systems) a Use OEM (original b Use CMMS Task E: Maintain a working spare c Contact and interact with d Track and order spare equipment manufacturer) (computerized maintenance parts inventory approved vendors parts and components manuals management systems) Task F: Interpret and review utility, process system/equipment, plumbing, b Review and change a Read and comprehend ductwork, architectural and HVAC P&IDs or system system schematics P&IDs (piping and instrumentation schematics diagrams) Task G: Evaluate and optimize a Offer ideas for system systems and components improvements

JOB FUNCTIONS COMPETENCIES 10. Comply with Environmental

Regulations Task A: Comply with EPA rules and a Dispose of waste oils and b Dispose of hazardous regulations when disposing of waste refrigerants wastes products 11. Maintain Safety of Systems Task A: Monitor and maintain a Obtain required permits b Perform required air c Follow company specific confined space entries and authorization monitoring procedures a Gather required b Obtain required permits c Follow company-specific Task B: Perform hot work procedures equipment and authorization procedures a Obtain required permits b Lock out and tag out all c Fill out forms and file Task C: Conduct Lockout Tagout and authorization potential energies according to procedures Task D: Perform continual a Maintain an orderly and housekeeping clean working area 12. Manage People a Effectively communicate Task A: Communicate with peers ideas through verbal and written forms a Interact constructively Task B: Interact with peers with peers and teams a Collaborate and Task C: Collaborate with peers and coordinate with outside vendors vendors 13. Manage Information a Write clear and concise Task A: Write SOPs technical documents using technical writing skills. a Make all needed entries in Task B: Make logbook entries logbooks a Communicate job-related information with peers and Task C: Share information other shifts using e-mail, logbooks, etc. a Find any needed b Find information needed Task D: Obtain information required to information that would be to order replacement perform work helpful with cause analysis components and parts and troubleshooting

Knowledge, Skills, and Equipment Facilities Technician

Academic Knowledge Technical Knowledge/Skills Tools/Equipment

Key to Knowledge/Skill Level Required: Key to Knowledge/Skill Level Required: Arbor Presses B – Basic I – Intermediate A – Advanced B – Basic I – Intermediate A – Advanced Bearing Heaters Bore Scope Key to Type of Knowledge/Skill Required Key to Type of Knowledge/Skill Required Chemical Test Kits C – Conceptual P – Practical/Applied C – Conceptual P – Practical/Applied Chlorine Test Kit Conductivity Meters Level Type Level TypeAseptic Technique (Gowning; Confined Space Entry/Retrieval Equipment Algebra ...... B PLaminar Flow Hoods; BSCs) ...... A Fall ArrestP Equipment Biology ...... B AutoclaveC Theory/Practice ...... I Flow GaugesC Chemistry ...... B BoilersC ...... A Gasket CuttersP Computer Skills and ...... Chemical Handling...... B Gear PullersP microcomputer CIP; SIP ...... I Hand ToolsP Applications (MS Office) ...... I CleanP Steam Generators ...... A Hoists P Regulatory Affairs ...... I DepyrogenationP ...... I HydraulicP Presses English...... I Electricity/ElectronicsP ...... I Laser AlignersP Environmental Science ...... B FallC Prevention (Heights) ...... A Levels P Health Science/ GMPs ...... I MicrometersP Industrial Hygiene ...... B HydraulicsC ...... A MultimetersP Logic/Critical Instrumentation (Process Ph Meters Thinking/Cause Controls and Calibration) ...... I Pipe ThreadingP Equipment Analysis ...... A LockP -Out/Tag-Out (LOTO) ...... A Power ToolsP Microbiology ...... B LyophilizationC ...... B PrecisionC Measuring Equipment Physics...... B MobileP Elevated Work Platforms ...... A PressureP Gauges Social Science Office Equipment Operation ...... I ProfilometersP (Ethics, Psychology, Pharmaceutical Grade Waters Pyrometer Sociology) ...... B C(WFI; Water Pre- Treatment; Reverse Silt Density Index Statistics ...... B POsmosis, DI) ...... A ThermoP Graphic Cameras Technical Mathematics ...... I PlantP or Material Flow Torches Technical Writing ...... I P(Dirty/Clean) ...... A Vacuum/PressureP Pumps Pneumatics ...... A VibrationP Analyzers Powered Industrial Vehicles ...... A Water SoftenerP Test Kit Pumps ...... A WeldingP Equipment Sanitization ...... I P Technical Reading and Writing ...... I P Valves (Check Valves; Flow Control Valves, etc.) ...... A P Waste Water Treatment ...... A P