Senior Specialist, Quality Assurance Lot Disposition
Bristol Myers Squibb
August 07, 2026
Remote friendly (Bothell, WA)
United States
Operations
Position Summary
Senior Specialist of Quality Assurance – Lot Disposition (QALD), full-time at BMS Bothell, WA Cell Therapy manufacturing site. Ensure final drug products and incoming raw materials are released to market per internal procedures and cGMP.
Responsibilities
- Perform routine lot disposition for finished drug products and incoming raw materials; ensure cGMP documentation is complete, accounted for, and approved.
- Generate, review, and approve Certificate of Analysis vs. release specifications; approve EM data and document excursions in QMS.
- Communicate lot disposition status; monitor progress and issue status reports.
- Review lot genealogy for raw materials/components; confirm approved/released via MES or ERP.
- Conduct drug product lot disposition; generate/review/approve Release For Infusion (RFI).
- Assemble/review QA system documents (deviations, batch production records, test methods, specifications, controlled forms).
- Create/revise SOPs, work instructions, forms, and reference documents as needed.
- Support audits, CAPAs, and change controls; provide quality input for quality-related issue resolution.
- Act as QA SME for cGMP oversight during audits/regulatory inspections.
Qualifications & Skills
- 3–5 years in Quality in commercial/clinical biopharma, cellular therapy, or gene therapy.
- Bachelor’s in life/physical science (or equivalent education/work).
- Knowledge of cGMP and FDA guidance for biologics/cell therapy.
- Strong documentation practices; detail oriented.
- Direct lot disposition experience supporting cGMP product manufacturing/testing/disposition/distribution.
- Excellent written/verbal communication; cross-functional collaboration.
Work Shift
- Tuesday–Saturday with flexible start time.
Benefits (highlights)
- Health coverage (medical/pharmacy/dental/vision).
- Wellbeing support (e.g., EAP).
- 401(k) and protection benefits (e.g., short/long-term disability, life insurance).
- Paid time off (varies by employee status).
Application instruction
- If the role doesn’t perfectly match your resume, apply anyway.
Senior Specialist of Quality Assurance – Lot Disposition (QALD), full-time at BMS Bothell, WA Cell Therapy manufacturing site. Ensure final drug products and incoming raw materials are released to market per internal procedures and cGMP.
Responsibilities
- Perform routine lot disposition for finished drug products and incoming raw materials; ensure cGMP documentation is complete, accounted for, and approved.
- Generate, review, and approve Certificate of Analysis vs. release specifications; approve EM data and document excursions in QMS.
- Communicate lot disposition status; monitor progress and issue status reports.
- Review lot genealogy for raw materials/components; confirm approved/released via MES or ERP.
- Conduct drug product lot disposition; generate/review/approve Release For Infusion (RFI).
- Assemble/review QA system documents (deviations, batch production records, test methods, specifications, controlled forms).
- Create/revise SOPs, work instructions, forms, and reference documents as needed.
- Support audits, CAPAs, and change controls; provide quality input for quality-related issue resolution.
- Act as QA SME for cGMP oversight during audits/regulatory inspections.
Qualifications & Skills
- 3–5 years in Quality in commercial/clinical biopharma, cellular therapy, or gene therapy.
- Bachelor’s in life/physical science (or equivalent education/work).
- Knowledge of cGMP and FDA guidance for biologics/cell therapy.
- Strong documentation practices; detail oriented.
- Direct lot disposition experience supporting cGMP product manufacturing/testing/disposition/distribution.
- Excellent written/verbal communication; cross-functional collaboration.
Work Shift
- Tuesday–Saturday with flexible start time.
Benefits (highlights)
- Health coverage (medical/pharmacy/dental/vision).
- Wellbeing support (e.g., EAP).
- 401(k) and protection benefits (e.g., short/long-term disability, life insurance).
- Paid time off (varies by employee status).
Application instruction
- If the role doesn’t perfectly match your resume, apply anyway.