Specialist, QA Manufacturing Shop Floor Operations
Bristol Myers Squibb
August 22, 2026
On-site
Devens, MA
Operations
Position Summary:
- Provide 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations.
- Oversee and partner with operational areas to ensure compliance with BMS policies, standards, procedures, and Global cGMP.
Shift:
- Day shift, 6:00 a.m. to 6:30 p.m. (12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays).
Duties/Responsibilities:
- Perform routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain.
- Interpret problems and communicate clearly with management and team.
- Identify departures from approved procedures; respond independently and escalate complex issues.
- Execute and document operational verification in MES; observe manufacturing for cleanroom/aseptic behavior.
- Provide quality oversight for return to service plans.
- Conduct area walkthroughs; identify quality issues, propose remediations, and support implementation.
- Propose improvements to programs/procedures/practices.
- Review batch records/QC testing records; review and provide feedback on forms/logbooks/procedures.
- Maintain learning plan compliance; support integration of newer team members.
- Independently approve deviation records using QRM principles.
- Review/interpret investigation conclusions and provide constructive feedback.
- Participate in quality and shift meetings; champion quality culture.
Qualifications:
- Action-oriented; decision-making, relationship-building, problem-solving, analytical thinking.
- Understand and apply internal policies/procedures/quality principles.
- Prior quality experience: batch record review, material disposition, change control, complaints, deviations, investigations, CAPA.
- Detail-oriented; meet deadlines; prioritize under changing priorities.
- Communicate effectively (verbal and technical writing); active listening.
- Able to work in pharmaceutical cleanroom environments.
- Experience with GxP systems (e.g., MES, SAP/ERP, LIMS, electronic logbooks/forms).
- Digital tools: Microsoft Power Automate, Smartsheet, Tableau, etc.
Education/Experience:
- Bachelor’s degree in STEM (or HS/associate with equivalent education/work).
- 2+ years relevant cGMP experience, including 1+ year manufacturing site experience.
- FDA/EMA biopharmaceutical or cell therapy regulatory experience.
Compensation/Benefits (as stated):
- $40.16–$48.67 per hour (Devens, MA, US).
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k) and insurance benefits.
- Paid time off (flexible/unlimited for US exempt employees; annual paid vacation/holidays for some hourly roles).
- Provide 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations.
- Oversee and partner with operational areas to ensure compliance with BMS policies, standards, procedures, and Global cGMP.
Shift:
- Day shift, 6:00 a.m. to 6:30 p.m. (12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays).
Duties/Responsibilities:
- Perform routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain.
- Interpret problems and communicate clearly with management and team.
- Identify departures from approved procedures; respond independently and escalate complex issues.
- Execute and document operational verification in MES; observe manufacturing for cleanroom/aseptic behavior.
- Provide quality oversight for return to service plans.
- Conduct area walkthroughs; identify quality issues, propose remediations, and support implementation.
- Propose improvements to programs/procedures/practices.
- Review batch records/QC testing records; review and provide feedback on forms/logbooks/procedures.
- Maintain learning plan compliance; support integration of newer team members.
- Independently approve deviation records using QRM principles.
- Review/interpret investigation conclusions and provide constructive feedback.
- Participate in quality and shift meetings; champion quality culture.
Qualifications:
- Action-oriented; decision-making, relationship-building, problem-solving, analytical thinking.
- Understand and apply internal policies/procedures/quality principles.
- Prior quality experience: batch record review, material disposition, change control, complaints, deviations, investigations, CAPA.
- Detail-oriented; meet deadlines; prioritize under changing priorities.
- Communicate effectively (verbal and technical writing); active listening.
- Able to work in pharmaceutical cleanroom environments.
- Experience with GxP systems (e.g., MES, SAP/ERP, LIMS, electronic logbooks/forms).
- Digital tools: Microsoft Power Automate, Smartsheet, Tableau, etc.
Education/Experience:
- Bachelor’s degree in STEM (or HS/associate with equivalent education/work).
- 2+ years relevant cGMP experience, including 1+ year manufacturing site experience.
- FDA/EMA biopharmaceutical or cell therapy regulatory experience.
Compensation/Benefits (as stated):
- $40.16–$48.67 per hour (Devens, MA, US).
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k) and insurance benefits.
- Paid time off (flexible/unlimited for US exempt employees; annual paid vacation/holidays for some hourly roles).