Senior Specialist, Quality Assurance Laboratory Operations
Bristol Myers Squibb
July 02, 2026
On-site
Devens, MA
Operations
Position Summary
- Quality Assurance Shop Floor (24x7 coverage) supporting Manufacturing, Quality Control labs, and Warehouse/Packout operations. Monday–Friday day shift; oversees and partners with operational areas to ensure compliance with BMS policies/standards/procedures and Global cGMP.
Key Responsibilities
- Provide QA oversight; identify deviations from approved procedures; independently respond/escalate critical issues.
- Perform/document operational verification; observe clean room behaviors/aseptic techniques.
- Lead area walkthroughs (Gemba), coordinate remediations, and drive implementation alignment.
- Own/review/approve GxP Floor records (e.g., procedures, CAPAs, change controls, impact assessments, documentation, deviations); support deviation/alarm and other Quality System/Batches as requested.
- Author/review/approve procedural documents; act as QA representative in governance forums and cross-functional meetings.
- Track process performance via data/analytics; establish KPIs/standard work databases; champion quality culture and learning.
- Serve as SME for risk assessments, change controls, and GxP electronic systems (e.g., BMSDocs, CELabs, MES, SAP, etc.).
Qualifications & Required/Preferred Skills
- Ability to interpret/apply SOPs, policies, and regulatory guidelines.
- Strong computer/digital skills (MS Office; Power Automate/Smartsheet/Tableau preferred).
- Data interpretation; critical thinking and clear written/verbal communication.
- Quality management systems experience (change control, deviations, investigations, CAPA, product complaints).
- 4+ years relevant cGMP experience (prefer 1+ year site/manufacturing). FDA/EMA biopharma/cell therapy experience preferred.
- STEM bachelor’s preferred (HS/AA may be considered).
Benefits (if eligible)
- Health coverage (medical/pharmacy/dental/vision); wellbeing programs (EAP); 401(k); life/disability/insurance.
- Paid time off (e.g., flexible time off for US exempt employees or vacation + holidays for specific locations/categories).
Application Instructions
- Apply for the role.
- Quality Assurance Shop Floor (24x7 coverage) supporting Manufacturing, Quality Control labs, and Warehouse/Packout operations. Monday–Friday day shift; oversees and partners with operational areas to ensure compliance with BMS policies/standards/procedures and Global cGMP.
Key Responsibilities
- Provide QA oversight; identify deviations from approved procedures; independently respond/escalate critical issues.
- Perform/document operational verification; observe clean room behaviors/aseptic techniques.
- Lead area walkthroughs (Gemba), coordinate remediations, and drive implementation alignment.
- Own/review/approve GxP Floor records (e.g., procedures, CAPAs, change controls, impact assessments, documentation, deviations); support deviation/alarm and other Quality System/Batches as requested.
- Author/review/approve procedural documents; act as QA representative in governance forums and cross-functional meetings.
- Track process performance via data/analytics; establish KPIs/standard work databases; champion quality culture and learning.
- Serve as SME for risk assessments, change controls, and GxP electronic systems (e.g., BMSDocs, CELabs, MES, SAP, etc.).
Qualifications & Required/Preferred Skills
- Ability to interpret/apply SOPs, policies, and regulatory guidelines.
- Strong computer/digital skills (MS Office; Power Automate/Smartsheet/Tableau preferred).
- Data interpretation; critical thinking and clear written/verbal communication.
- Quality management systems experience (change control, deviations, investigations, CAPA, product complaints).
- 4+ years relevant cGMP experience (prefer 1+ year site/manufacturing). FDA/EMA biopharma/cell therapy experience preferred.
- STEM bachelor’s preferred (HS/AA may be considered).
Benefits (if eligible)
- Health coverage (medical/pharmacy/dental/vision); wellbeing programs (EAP); 401(k); life/disability/insurance.
- Paid time off (e.g., flexible time off for US exempt employees or vacation + holidays for specific locations/categories).
Application Instructions
- Apply for the role.