Specialist, Quality Assurance Shop Floor
Bristol Myers Squibb
6 days ago
On-site
Devens, MA
Operations
Position Summary
- Quality Assurance Shop Floor team provides 24x7 Quality collaboration/oversight of site operations (Manufacturing, Quality Control labs, Warehouse).
- Oversee/partner with operational areas to ensure compliance with BMS policies/standards/procedures and Global cGMP.
- Shift: Day shift, Panama schedule (12-hour shifts; 2-2-3 cycle incl. weekends/holidays; 6am–6pm).
Duties/Responsibilities
- Provide routine quality on-the-floor oversight; triage unexpected events with Manufacturing, Quality Labs, Supply Chain.
- Interpret problems and communicate clearly to management/team.
- Identify departures from approved procedures; respond independently; escalate complex issues.
- Perform/document operational verification in MES per approved procedures.
- Observe operations; identify departures (procedures, cleanroom behaviors, aseptic techniques).
- Quality oversight for pre-planned return-to-service plans.
- Conduct area walkthroughs; identify quality issues; propose remediations and implementation support.
- Identify improvements to programs/procedures/practices.
- Review batch records/QC testing records; review/provide feedback on forms, logbooks, and procedures.
- Maintain compliance with learning plan; support integration of newer team members.
- Independently approve deviations in the QMS consistent with quality risk management.
- Review/interpret investigation conclusions and provide constructive feedback.
- Participate in quality/shift meetings; build partner relationships and champion quality culture.
Qualifications
- Action-oriented; decision-making, relationship building, problem-solving, analytical thinking.
- Apply internal policies/procedures and quality principles.
- Prior quality experience: batch record review, material disposition, change control, product complaints, deviations, investigations, CAPA.
- Able to diagnose unfolding problems and propose practical solutions.
- Detail-oriented; prioritize work and meet deadlines.
- Communicate effectively cross-functionally (technical writing/verbal) and actively listen.
- Cleanroom/pharma environment experience.
- Familiar with QMS record handling (change control, complaints, deviations, investigations, CAPA).
- Experience with GxP electronic systems (MES for electronic batch records; ERP such as SAP; lab systems; electronic logbooks/forms).
- Digital tools: Microsoft Power Automate, Smartsheet, Tableau (or similar).
Education/Experience
- STEM bachelor’s preferred; high school diploma or associate’s with equivalent education/work accepted.
- 2+ years relevant cGMP experience; 1+ year manufacturing site experience.
- FDA/EMA regulations experience in biopharma/cell therapy manufacturing.
Benefits (if applicable)
- Health: medical, pharmacy, dental, vision.
- Wellbeing support (e.g., EAP).
- Financial: 401(k), disability, life insurance, etc.
- Paid Time Off options per location/eligibility (flex time/paid vacation) plus possible additional eligible time off.
Application Instructions
- Apply for the role even if your resume doesn’t perfectly match requirements.
- Quality Assurance Shop Floor team provides 24x7 Quality collaboration/oversight of site operations (Manufacturing, Quality Control labs, Warehouse).
- Oversee/partner with operational areas to ensure compliance with BMS policies/standards/procedures and Global cGMP.
- Shift: Day shift, Panama schedule (12-hour shifts; 2-2-3 cycle incl. weekends/holidays; 6am–6pm).
Duties/Responsibilities
- Provide routine quality on-the-floor oversight; triage unexpected events with Manufacturing, Quality Labs, Supply Chain.
- Interpret problems and communicate clearly to management/team.
- Identify departures from approved procedures; respond independently; escalate complex issues.
- Perform/document operational verification in MES per approved procedures.
- Observe operations; identify departures (procedures, cleanroom behaviors, aseptic techniques).
- Quality oversight for pre-planned return-to-service plans.
- Conduct area walkthroughs; identify quality issues; propose remediations and implementation support.
- Identify improvements to programs/procedures/practices.
- Review batch records/QC testing records; review/provide feedback on forms, logbooks, and procedures.
- Maintain compliance with learning plan; support integration of newer team members.
- Independently approve deviations in the QMS consistent with quality risk management.
- Review/interpret investigation conclusions and provide constructive feedback.
- Participate in quality/shift meetings; build partner relationships and champion quality culture.
Qualifications
- Action-oriented; decision-making, relationship building, problem-solving, analytical thinking.
- Apply internal policies/procedures and quality principles.
- Prior quality experience: batch record review, material disposition, change control, product complaints, deviations, investigations, CAPA.
- Able to diagnose unfolding problems and propose practical solutions.
- Detail-oriented; prioritize work and meet deadlines.
- Communicate effectively cross-functionally (technical writing/verbal) and actively listen.
- Cleanroom/pharma environment experience.
- Familiar with QMS record handling (change control, complaints, deviations, investigations, CAPA).
- Experience with GxP electronic systems (MES for electronic batch records; ERP such as SAP; lab systems; electronic logbooks/forms).
- Digital tools: Microsoft Power Automate, Smartsheet, Tableau (or similar).
Education/Experience
- STEM bachelor’s preferred; high school diploma or associate’s with equivalent education/work accepted.
- 2+ years relevant cGMP experience; 1+ year manufacturing site experience.
- FDA/EMA regulations experience in biopharma/cell therapy manufacturing.
Benefits (if applicable)
- Health: medical, pharmacy, dental, vision.
- Wellbeing support (e.g., EAP).
- Financial: 401(k), disability, life insurance, etc.
- Paid Time Off options per location/eligibility (flex time/paid vacation) plus possible additional eligible time off.
Application Instructions
- Apply for the role even if your resume doesn’t perfectly match requirements.