Specialist, Quality Assurance Shop Floor, Cell Therapy
Bristol Myers Squibb
August 13, 2026
On-site
Devens, MA
Operations
Position Summary
- Oversee and provide 24x7 Quality collaboration and oversight of site operations (Manufacturing, Quality Control labs, Supply Chain/Warehouse) to ensure compliance with BMS policies/standards/procedures and Global cGMP.
- Night shift: 6 PM–6 AM, Panama schedule (12-hour shifts; 2-2-3 cycle incl. weekends/holidays).
Duties/Responsibilities
- Provide on-the-floor QA oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain.
- Interpret issues and communicate clearly to management and stakeholders.
- Identify departures from approved procedures; respond independently and escalate complex issues.
- Perform and document operational verification; observe cleanroom/aseptic technique and procedural compliance.
- Review batch records, logbooks, and QC testing records; resolve discrepancies and escalate.
- Approve/review GxP records (incl. deviations, and other Quality System Records as requested); approve deviations consistent with quality risk management.
- Support return-to-service plans; internal/external inspections.
- Identify improvement opportunities; support continuous improvement projects.
- Maintain learning plan and support integration of newer team members.
- Participate in quality/shift and cross-functional meetings; champion quality culture.
- Develop SME capability for QA electronic systems (e.g., MES/Syncade, SAP, Infinity/BMSDocs, CELabs, ValGenesis, DeltaV, Maximo).
Qualifications (required/preferred)
- Action-oriented decision-making, problem-solving, analytical thinking; apply quality principles and internal policies.
- Prior QA experience with batch record review, material disposition, change control, product complaints, deviations/investigations, CAPA.
- Detail-oriented; meet deadlines; work in fast-paced, changing-priority environments.
- Strong technical writing/verbal communication; independent data-based decisions and escalation judgment.
- Cleanroom experience; GxP record quality management system experience.
- Preferred: STEM bachelor’s; 2+ years cGMP (1+ year manufacturing site); FDA/EMA exposure in biopharma/cell therapy.
- Experience with GxP electronic systems (MES, ERP/SAP, LIMS, electronic logbooks/forms); MS Office.
Benefits / Compensation (as stated)
- Pay range (Devens, MA): $40.16–$48.67/hour; incentive cash/stock may be available.
- Health, wellbeing, 401(k), disability/life/insurance, and other listed protections.
- Paid time off options (flexible time off or vacation + holidays depending on role/location/eligibility).
- Oversee and provide 24x7 Quality collaboration and oversight of site operations (Manufacturing, Quality Control labs, Supply Chain/Warehouse) to ensure compliance with BMS policies/standards/procedures and Global cGMP.
- Night shift: 6 PM–6 AM, Panama schedule (12-hour shifts; 2-2-3 cycle incl. weekends/holidays).
Duties/Responsibilities
- Provide on-the-floor QA oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain.
- Interpret issues and communicate clearly to management and stakeholders.
- Identify departures from approved procedures; respond independently and escalate complex issues.
- Perform and document operational verification; observe cleanroom/aseptic technique and procedural compliance.
- Review batch records, logbooks, and QC testing records; resolve discrepancies and escalate.
- Approve/review GxP records (incl. deviations, and other Quality System Records as requested); approve deviations consistent with quality risk management.
- Support return-to-service plans; internal/external inspections.
- Identify improvement opportunities; support continuous improvement projects.
- Maintain learning plan and support integration of newer team members.
- Participate in quality/shift and cross-functional meetings; champion quality culture.
- Develop SME capability for QA electronic systems (e.g., MES/Syncade, SAP, Infinity/BMSDocs, CELabs, ValGenesis, DeltaV, Maximo).
Qualifications (required/preferred)
- Action-oriented decision-making, problem-solving, analytical thinking; apply quality principles and internal policies.
- Prior QA experience with batch record review, material disposition, change control, product complaints, deviations/investigations, CAPA.
- Detail-oriented; meet deadlines; work in fast-paced, changing-priority environments.
- Strong technical writing/verbal communication; independent data-based decisions and escalation judgment.
- Cleanroom experience; GxP record quality management system experience.
- Preferred: STEM bachelor’s; 2+ years cGMP (1+ year manufacturing site); FDA/EMA exposure in biopharma/cell therapy.
- Experience with GxP electronic systems (MES, ERP/SAP, LIMS, electronic logbooks/forms); MS Office.
Benefits / Compensation (as stated)
- Pay range (Devens, MA): $40.16–$48.67/hour; incentive cash/stock may be available.
- Health, wellbeing, 401(k), disability/life/insurance, and other listed protections.
- Paid time off options (flexible time off or vacation + holidays depending on role/location/eligibility).