Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm)
Bristol Myers Squibb
4 days ago
On-site
Devens, MA
Operations
Position: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am–6pm)
Responsibilities
- Provide QA oversight to Manufacturing/QC/Warehouse/Packout; identify deviations from approved procedures, respond independently, and escalate critical issues.
- Perform/document operational verification; observe operations for departures from cleanroom behaviors and aseptic techniques.
- Develop/review/approve temporary and non-routine procedures for event response.
- Coordinate/lead area walkthroughs; negotiate remediations and drive implementation alignment.
- Lead/participate in Gemba walks and cross-functional triage meetings.
- Communicate and resolve discrepancies; author/review/approve procedural documents.
- Own quality decision-making for unexpected floor events; triage and determine deviations.
- Review/quality-approve GxP records (e.g., procedures, batch records, deviations); support deviation/alarm approval and other quality system records.
- Maintain learning-plan compliance; guide/train QA personnel; support audit presentations.
- Assess discrepancies for quality system entry; approve deviations as applicable.
- Serve as SME for risk assessments/change controls; lead meetings; influence/improve programs.
- Establish KPIs/standard work databases; act as project manager for planning/meeting execution.
- Develop as SME for QA electronic systems (e.g., BMSDocs, CELabs, MES, SAP, etc.); understand GMP-related systems (QRM, document/data governance, monitoring/reporting).
Qualifications / Required Skills
- Research/interpret/apply SOPs, policies, and regulatory guidelines.
- Strong written/verbal communication; present technical data effectively.
- Data interpretation and problem-solving; detail-oriented; meet deadlines.
- Computer proficiency (MS Office and new software); learn analytical/digital tools.
- Demonstrated quality management system experience (change control, complaints, deviations, investigations, CAPA).
- Demonstrated experience with GxP electronic systems (QMS, MES/electronic batch records, ERP like SAP, LIMS, electronic logbooks/forms).
Preferred Qualifications
- STEM bachelor’s; or HS/Associate with equivalent experience.
- 4+ years relevant cGMP experience, preferably 1+ year manufacturing site experience; FDA/EMA experience in biopharma/cell therapy.
Benefits (high-level)
- Health coverage; wellbeing support; 401(k); disability and life insurance; paid time off (per eligibility).
Responsibilities
- Provide QA oversight to Manufacturing/QC/Warehouse/Packout; identify deviations from approved procedures, respond independently, and escalate critical issues.
- Perform/document operational verification; observe operations for departures from cleanroom behaviors and aseptic techniques.
- Develop/review/approve temporary and non-routine procedures for event response.
- Coordinate/lead area walkthroughs; negotiate remediations and drive implementation alignment.
- Lead/participate in Gemba walks and cross-functional triage meetings.
- Communicate and resolve discrepancies; author/review/approve procedural documents.
- Own quality decision-making for unexpected floor events; triage and determine deviations.
- Review/quality-approve GxP records (e.g., procedures, batch records, deviations); support deviation/alarm approval and other quality system records.
- Maintain learning-plan compliance; guide/train QA personnel; support audit presentations.
- Assess discrepancies for quality system entry; approve deviations as applicable.
- Serve as SME for risk assessments/change controls; lead meetings; influence/improve programs.
- Establish KPIs/standard work databases; act as project manager for planning/meeting execution.
- Develop as SME for QA electronic systems (e.g., BMSDocs, CELabs, MES, SAP, etc.); understand GMP-related systems (QRM, document/data governance, monitoring/reporting).
Qualifications / Required Skills
- Research/interpret/apply SOPs, policies, and regulatory guidelines.
- Strong written/verbal communication; present technical data effectively.
- Data interpretation and problem-solving; detail-oriented; meet deadlines.
- Computer proficiency (MS Office and new software); learn analytical/digital tools.
- Demonstrated quality management system experience (change control, complaints, deviations, investigations, CAPA).
- Demonstrated experience with GxP electronic systems (QMS, MES/electronic batch records, ERP like SAP, LIMS, electronic logbooks/forms).
Preferred Qualifications
- STEM bachelor’s; or HS/Associate with equivalent experience.
- 4+ years relevant cGMP experience, preferably 1+ year manufacturing site experience; FDA/EMA experience in biopharma/cell therapy.
Benefits (high-level)
- Health coverage; wellbeing support; 401(k); disability and life insurance; paid time off (per eligibility).