Senior QA Lot Disposition Lead — Cell Therapy

Bristol-Myers Squibb; Bothell (WA); On-site; USD 92,000 - 112,000; Full time

Job summary

Bristol Myers Squibb seeks a Senior Specialist in Quality Assurance Lot Disposition at the Bothell, WA site. The role focuses on final drug product and raw material release to market under cGMP, reporting to the Senior QA Manager.

Responsibilities include COA management, EM data approval, lot genealogy review, and SOP development. Ideal candidates have 3–5 years in QA within biopharma, a life/physical science degree, and strong documentation, cross-functional collaboration, and communication

Qualifications

• 3–5 years in a quality role within commercial or clinical biopharmaceuticals.
• Knowledge of cGMP and FDA guidance for biologics/cell therapy.
• Detail oriented with strong documentation practices.
• Experience with lot disposition for manufacturing, testing, disposition, and distribution.

Responsibilities

• Conduct routine lot disposition activities for finished products and incoming materials.
• Generate, review, and approve COAs; ensure EM data and excursions are documented.
• Review lot genealogy for raw materials and components; ensure release approval.
• Perform drug product lot disposition and release documentation (RFI).
• Create/ revise SOPs, WI, forms; support audits, CAPAs, change controls.
• Represent QA in project meetings and regulatory inspections.

Skills

Quality Assurance

Lot disposition

cGMP knowledge

Documentation practices

Cross-functional collaboration

Communication

Education

Bachelor’s degree in life or physical science

Job description

Bristol Myers Squibb seeks a Senior Specialist in Quality Assurance Lot Disposition at the Bothell, WA site. The role focuses on final drug product and raw material release to market under cGMP, reporting to the Senior QA Manager.

Responsibilities include COA management, EM data approval, lot genealogy review, and SOP development. Ideal candidates have 3–5 years in QA within biopharma, a life/physical science degree, and strong documentation, cross-functional collaboration, and communication