Senior Specialist, Quality Assurance Shop Floor, Cell Therapy
Bristol Myers Squibb
July 03, 2026
On-site
Devens, MA
Operations
Position Summary
The Quality Assurance Shop Floor team provides 24x7 quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
Reports to: Shift Manager, Quality Assurance Shop Floor.
Schedule: Rotating 2-3-2 Panama (6am to 6pm) day shift.
Key Responsibilities
- Provide on-the-floor quality oversight to Manufacturing/QC/Warehouse/Packout; identify departures from approved procedures and respond independently, escalating critical issues.
- Perform and document operational verification per approved procedures.
- Develop, review, and/or approve temporary and non-routine procedures for event response.
- Observe clean room behaviors and aseptic techniques; identify departures.
- Provide quality oversight for non-routine maintenance; review and approve return-to-service plans.
- Coordinate and lead area walkthroughs; negotiate remediations and drive implementation alignment.
- Own shift actions for departmental programs; propose improvements.
- Participate in Gemba walks.
- Review manufacturing/testing records for compliance; resolve discrepancies and escalate as required.
- Author/review/approve procedural documents.
- Maintain compliance with assigned learning plan; guide and train QA personnel (may own curriculum/content).
- Independently assess discrepancies for quality system entry and approve deviations (as applicable).
- Serve as SME for risk assessments, change controls, etc.; lead/represent function in cross-functional meetings.
Qualifications
- Ability to interpret and apply internal policies and regulatory guidelines.
- Proficient with MS Office and ability to learn new software; interpret complex data/results.
- Excellent written/verbal communication; present technical data to target audiences.
- Detail-oriented, task-focused; meet deadlines in a fast-paced environment.
- Ability to negotiate/influence, motivate, and foster a positive team environment; strong decision-making with creativity while maintaining compliance/quality.
Education/Experience (preferred/required)
- Bachelor’s in STEM preferred; high school diploma/associate degree may be considered.
- 4+ years relevant cGMP experience; preferably 1+ year manufacturing site experience; FDA/EMA biopharmaceutical or cell therapy experience preferred.
- Demonstrated experience with quality management systems.
- Demonstrated experience with electronic systems/databases such as MES and ERP.
Compensation/Benefits
- Devens, MA: $89,780 - $108,789 (starting compensation range).
- Health coverage; wellbeing programs; financial protection (401(k), disability, life insurance, etc.).
- Paid time off (details vary by employee category).
Application Instructions
- Apply even if your resume doesn’t perfectly match the role.
The Quality Assurance Shop Floor team provides 24x7 quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
Reports to: Shift Manager, Quality Assurance Shop Floor.
Schedule: Rotating 2-3-2 Panama (6am to 6pm) day shift.
Key Responsibilities
- Provide on-the-floor quality oversight to Manufacturing/QC/Warehouse/Packout; identify departures from approved procedures and respond independently, escalating critical issues.
- Perform and document operational verification per approved procedures.
- Develop, review, and/or approve temporary and non-routine procedures for event response.
- Observe clean room behaviors and aseptic techniques; identify departures.
- Provide quality oversight for non-routine maintenance; review and approve return-to-service plans.
- Coordinate and lead area walkthroughs; negotiate remediations and drive implementation alignment.
- Own shift actions for departmental programs; propose improvements.
- Participate in Gemba walks.
- Review manufacturing/testing records for compliance; resolve discrepancies and escalate as required.
- Author/review/approve procedural documents.
- Maintain compliance with assigned learning plan; guide and train QA personnel (may own curriculum/content).
- Independently assess discrepancies for quality system entry and approve deviations (as applicable).
- Serve as SME for risk assessments, change controls, etc.; lead/represent function in cross-functional meetings.
Qualifications
- Ability to interpret and apply internal policies and regulatory guidelines.
- Proficient with MS Office and ability to learn new software; interpret complex data/results.
- Excellent written/verbal communication; present technical data to target audiences.
- Detail-oriented, task-focused; meet deadlines in a fast-paced environment.
- Ability to negotiate/influence, motivate, and foster a positive team environment; strong decision-making with creativity while maintaining compliance/quality.
Education/Experience (preferred/required)
- Bachelor’s in STEM preferred; high school diploma/associate degree may be considered.
- 4+ years relevant cGMP experience; preferably 1+ year manufacturing site experience; FDA/EMA biopharmaceutical or cell therapy experience preferred.
- Demonstrated experience with quality management systems.
- Demonstrated experience with electronic systems/databases such as MES and ERP.
Compensation/Benefits
- Devens, MA: $89,780 - $108,789 (starting compensation range).
- Health coverage; wellbeing programs; financial protection (401(k), disability, life insurance, etc.).
- Paid time off (details vary by employee category).
Application Instructions
- Apply even if your resume doesn’t perfectly match the role.