Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm)
Bristol Myers Squibb
3 months ago
On-site
Devens, MA
Operations
Position: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am–6pm). Rotating 2-3-2 Panama schedule; reports to Shift Manager, Quality Assurance Shop Floor.
Key Responsibilities:
- Provide QA oversight to Manufacturing/QC/Warehouse/Packout; independently identify departures from approved procedures, resolve complex issues, and escalate critical issues.
- Perform/record operational verification; develop/review/approve temporary and non-routine procedures for event response.
- Observe manufacturing for cleanroom/aseptic technique adherence; coordinate walkthroughs to identify quality issues and negotiate/drive remediation plans.
- Author/review/approve procedural documents; own/review/quality-approve GxP records (e.g., procedures, batch records, deviations) and approve deviations as applicable.
- Support deviation and alarm approvals; assess discrepancies for quality system entry; participate in Gemba walks and cross-functional triage meetings.
- Maintain compliance with learning plan; guide/train QA personnel; may own training curriculum.
- Lead meetings and represent QA in cross-functional settings; establish KPIs/standard work databases.
- Act as SME for electronic systems (e.g., BMSDocs, CELabs, MES, SAP, etc.) and GMP-related systems (quality risk management, document/data governance, monitoring/reporting).
Qualifications/Requirements:
- Ability to interpret/apply internal SOPs, policies, and regulatory guidelines.
- Strong computer skills (MS Office and new software); data interpretation and problem-solving.
- Excellent written/verbal communication; detail-oriented; strong decision-making while maintaining compliance/quality.
- Demonstrated experience with quality management systems (change control, product complaints, deviations, investigations, CAPA).
- Demonstrated experience with GxP electronic systems (QMS, MES/electronic batch records, ERP like SAP, LIMS, electronic logbooks/forms).
Preferred:
- Bachelor’s degree in STEM.
- 4+ years relevant cGMP experience (preferably 1+ year manufacturing site); FDA/EMA biopharma or cell therapy regulation experience.
- Experience with analytical tools (Power Automate, Smartsheet, Tableau).
Compensation/Benefits (if applicable):
- Devens, MA: $89,780–$108,789 base range; additional incentive opportunities may apply.
- Health coverage; wellbeing programs; 401(k) and insurance benefits; Paid Time Off (flexible time off/paid vacation details vary by location).
Application instruction:
- If the role intrigues you but doesn’t perfectly match your resume, you are encouraged to apply anyway.
Key Responsibilities:
- Provide QA oversight to Manufacturing/QC/Warehouse/Packout; independently identify departures from approved procedures, resolve complex issues, and escalate critical issues.
- Perform/record operational verification; develop/review/approve temporary and non-routine procedures for event response.
- Observe manufacturing for cleanroom/aseptic technique adherence; coordinate walkthroughs to identify quality issues and negotiate/drive remediation plans.
- Author/review/approve procedural documents; own/review/quality-approve GxP records (e.g., procedures, batch records, deviations) and approve deviations as applicable.
- Support deviation and alarm approvals; assess discrepancies for quality system entry; participate in Gemba walks and cross-functional triage meetings.
- Maintain compliance with learning plan; guide/train QA personnel; may own training curriculum.
- Lead meetings and represent QA in cross-functional settings; establish KPIs/standard work databases.
- Act as SME for electronic systems (e.g., BMSDocs, CELabs, MES, SAP, etc.) and GMP-related systems (quality risk management, document/data governance, monitoring/reporting).
Qualifications/Requirements:
- Ability to interpret/apply internal SOPs, policies, and regulatory guidelines.
- Strong computer skills (MS Office and new software); data interpretation and problem-solving.
- Excellent written/verbal communication; detail-oriented; strong decision-making while maintaining compliance/quality.
- Demonstrated experience with quality management systems (change control, product complaints, deviations, investigations, CAPA).
- Demonstrated experience with GxP electronic systems (QMS, MES/electronic batch records, ERP like SAP, LIMS, electronic logbooks/forms).
Preferred:
- Bachelor’s degree in STEM.
- 4+ years relevant cGMP experience (preferably 1+ year manufacturing site); FDA/EMA biopharma or cell therapy regulation experience.
- Experience with analytical tools (Power Automate, Smartsheet, Tableau).
Compensation/Benefits (if applicable):
- Devens, MA: $89,780–$108,789 base range; additional incentive opportunities may apply.
- Health coverage; wellbeing programs; 401(k) and insurance benefits; Paid Time Off (flexible time off/paid vacation details vary by location).
Application instruction:
- If the role intrigues you but doesn’t perfectly match your resume, you are encouraged to apply anyway.