Senior Specialist, QA Shop Floor M-F, Cell Therapy
Bristol Myers Squibb
August 15, 2026
Remote friendly (Devens, MA)
United States
Operations
Position Summary
- 24x7 Quality collaboration/oversight for site operations (Manufacturing, Quality Control labs, Warehouse Operations).
- Monday–Friday, day shift. Oversees/partners with operational areas to ensure compliance with BMS policies, standards, procedures, and Global cGMP.
- Individual contributor Shop Floor QA Senior Specialist (reports to Senior Manager, Quality Assurance Shop Floor M-F).
Responsibilities
- Provide QA oversight; identify departures from approved procedures and independently resolve/escalate critical issues.
- Perform/document operational verification; observe clean room behaviors/aseptic techniques.
- Lead walkthroughs/Gemba walks; coordinate remediation and align implementation plans.
- Own/review/approve GxP records (procedures, CAPAs, change controls, impact assessments, documentation, deviations); support deviation/alarm and batch record review as requested.
- Communicate/resolve discrepancies; author and approve procedural documents.
- Maintain learning compliance; guide/train QA personnel and may own training content.
- Manage KPIs/standard work databases; function as project manager (organize/run meetings).
- Develop SME access for electronic systems (e.g., BMSDocs, MES, SAP, etc.); be familiar with GMP-related systems (QRM, document/data governance, monitoring/reporting).
Qualifications (Required/Preferred)
- Ability to interpret/apply SOPs, policies, regulatory guidelines.
- Proficient in MS Office/digital tools; interpret data/results and communicate effectively.
- 4+ years relevant cGMP experience; 1+ year manufacturing site experience preferred; FDA/EMA biopharma/cell therapy preferred.
- Demonstrated quality management systems experience (change control, deviations, investigations, CAPA, etc.) and GxP electronic systems (QMS, MES, ERP such as SAP, LIMS, electronic logbooks/forms).
- STEM bachelor’s preferred; HS/Associates with equivalent experience considered.
Benefits/Compensation (explicit)
- Devens, MA: $89,780–$108,789; additional incentives may be available.
- Health, wellbeing, 401(k), disability/life insurance and other listed benefits; PTO (details by employee type/location).
- 24x7 Quality collaboration/oversight for site operations (Manufacturing, Quality Control labs, Warehouse Operations).
- Monday–Friday, day shift. Oversees/partners with operational areas to ensure compliance with BMS policies, standards, procedures, and Global cGMP.
- Individual contributor Shop Floor QA Senior Specialist (reports to Senior Manager, Quality Assurance Shop Floor M-F).
Responsibilities
- Provide QA oversight; identify departures from approved procedures and independently resolve/escalate critical issues.
- Perform/document operational verification; observe clean room behaviors/aseptic techniques.
- Lead walkthroughs/Gemba walks; coordinate remediation and align implementation plans.
- Own/review/approve GxP records (procedures, CAPAs, change controls, impact assessments, documentation, deviations); support deviation/alarm and batch record review as requested.
- Communicate/resolve discrepancies; author and approve procedural documents.
- Maintain learning compliance; guide/train QA personnel and may own training content.
- Manage KPIs/standard work databases; function as project manager (organize/run meetings).
- Develop SME access for electronic systems (e.g., BMSDocs, MES, SAP, etc.); be familiar with GMP-related systems (QRM, document/data governance, monitoring/reporting).
Qualifications (Required/Preferred)
- Ability to interpret/apply SOPs, policies, regulatory guidelines.
- Proficient in MS Office/digital tools; interpret data/results and communicate effectively.
- 4+ years relevant cGMP experience; 1+ year manufacturing site experience preferred; FDA/EMA biopharma/cell therapy preferred.
- Demonstrated quality management systems experience (change control, deviations, investigations, CAPA, etc.) and GxP electronic systems (QMS, MES, ERP such as SAP, LIMS, electronic logbooks/forms).
- STEM bachelor’s preferred; HS/Associates with equivalent experience considered.
Benefits/Compensation (explicit)
- Devens, MA: $89,780–$108,789; additional incentives may be available.
- Health, wellbeing, 401(k), disability/life insurance and other listed benefits; PTO (details by employee type/location).