Bristol Myers Squibb
Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Senior Specialist, Quality Assurance Shop Floor, Cell Therapy
Join to apply for the Senior Specialist, Quality Assurance Shop Floor, Cell Therapy role at Bristol Myers Squibb.
Location: Devens, MA. Annual Salary: $89,780–$108,789. Schedule: B2 – 6pm–6am, rotating, onsite, 7 days/week.
Role Summary The Senior Specialist, QA Shop Floor will oversee GxP compliance across Manufacturing, QC, Warehouse, and Packout operations. The incumbent will partner with operational areas to ensure adherence to BMS policies, standards, procedures, and Global cGMP. The role includes quality decision‑making for unexpected events on the production floor, deviation triage, and quality record approval.
Responsibilities
Provide quality oversight to Manufacturing/QC/Warehouse/Packout operations; identify departures from approved procedures, respond to complex issues independently, and engage management on critical issues.
Document operational verification per approved procedures.
Develop, review, and approve temporary and non‑routine procedures for event response.
Observe manufacturing operations to identify departures from clean room behaviors and aseptic techniques.
Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans.
Own actions for departmental programs and propose improvements.
Communicate and resolve discrepancies independently and escalate as required.
Author, review, and approve procedural documents.
Maintain compliance with assigned learning plan; provide guidance and training for QA personnel.
May own training curriculum and content.
Independently assess discrepancies for entry into quality system and approve records as applicable.
Lead meetings and represent function at cross‑functional meetings.
Share data/knowledge within and across team; build & maintain strong relationships with partner functions.
May prioritize and assign tasks for the team.
Observe operations occurring on the floor and proactively identify risks and drive improvements.
Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
Able to influence others based on time and task commitments; organize/run meetings.
Obtain access to, and develop as an SME for, various electronic systems utilized by QA Shop Floor (e.g., BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity).
Familiar with GMP‑related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.
Knowledge and Skills
Research, understand, interpret, and apply internal SOPs, policies, and regulatory guidelines.
Proficient in MS Office and digital tools; ability to learn new software applications.
Interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
Excellent written and verbal skills; present technical data effectively to target audiences.
Work in a fast‑paced team environment and lead peers through changing priorities.
Detail oriented and task focused; meet deadlines and support work prioritization.
Negotiate and influence to craft mutually beneficial solutions.
Motivate and foster a positive team environment.
Strong decision‑making; think creatively while maintaining compliance and quality.
Experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
Experience with analytical computer/digital tools (Power Automate, Smartsheet, Tableau, etc.).
Experience with quality management systems; experience in GxP electronic systems such as QMS, MES, ERP (SAP), LIMS, electronic logbooks/forms.
Basic Requirements
Bachelor's degree in STEM field preferred; High school diploma or Associate's degree with equivalent combination of education and work experience may be considered.
4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience; experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Compensation Overview Devens – MA – US $89,780 – $108,789. Additional incentive cash and stock opportunities may be available.
Benefits Highlights Competitive benefits including medical, pharmacy, dental, vision, 401(k), paid national holidays, parental leave, tuition reimbursement, and BMS Living Life Better program.
EEO Statement Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
Job Function Quality Assurance.
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Location: Devens, MA. Annual Salary: $89,780–$108,789. Schedule: B2 – 6pm–6am, rotating, onsite, 7 days/week.
Role Summary The Senior Specialist, QA Shop Floor will oversee GxP compliance across Manufacturing, QC, Warehouse, and Packout operations. The incumbent will partner with operational areas to ensure adherence to BMS policies, standards, procedures, and Global cGMP. The role includes quality decision‑making for unexpected events on the production floor, deviation triage, and quality record approval.
Responsibilities
Provide quality oversight to Manufacturing/QC/Warehouse/Packout operations; identify departures from approved procedures, respond to complex issues independently, and engage management on critical issues.
Document operational verification per approved procedures.
Develop, review, and approve temporary and non‑routine procedures for event response.
Observe manufacturing operations to identify departures from clean room behaviors and aseptic techniques.
Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans.
Own actions for departmental programs and propose improvements.
Communicate and resolve discrepancies independently and escalate as required.
Author, review, and approve procedural documents.
Maintain compliance with assigned learning plan; provide guidance and training for QA personnel.
May own training curriculum and content.
Independently assess discrepancies for entry into quality system and approve records as applicable.
Lead meetings and represent function at cross‑functional meetings.
Share data/knowledge within and across team; build & maintain strong relationships with partner functions.
May prioritize and assign tasks for the team.
Observe operations occurring on the floor and proactively identify risks and drive improvements.
Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
Able to influence others based on time and task commitments; organize/run meetings.
Obtain access to, and develop as an SME for, various electronic systems utilized by QA Shop Floor (e.g., BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity).
Familiar with GMP‑related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.
Knowledge and Skills
Research, understand, interpret, and apply internal SOPs, policies, and regulatory guidelines.
Proficient in MS Office and digital tools; ability to learn new software applications.
Interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
Excellent written and verbal skills; present technical data effectively to target audiences.
Work in a fast‑paced team environment and lead peers through changing priorities.
Detail oriented and task focused; meet deadlines and support work prioritization.
Negotiate and influence to craft mutually beneficial solutions.
Motivate and foster a positive team environment.
Strong decision‑making; think creatively while maintaining compliance and quality.
Experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
Experience with analytical computer/digital tools (Power Automate, Smartsheet, Tableau, etc.).
Experience with quality management systems; experience in GxP electronic systems such as QMS, MES, ERP (SAP), LIMS, electronic logbooks/forms.
Basic Requirements
Bachelor's degree in STEM field preferred; High school diploma or Associate's degree with equivalent combination of education and work experience may be considered.
4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience; experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Compensation Overview Devens – MA – US $89,780 – $108,789. Additional incentive cash and stock opportunities may be available.
Benefits Highlights Competitive benefits including medical, pharmacy, dental, vision, 401(k), paid national holidays, parental leave, tuition reimbursement, and BMS Living Life Better program.
EEO Statement Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
Job Function Quality Assurance.
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