Quality Assurance Lot Disposition Specialist

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

Job summary

Bristol Myers Squibb in Bothell, WA seeks a Senior Specialist, Quality Assurance Lot Disposition to ensure final drug products and incoming materials are released to market following cGMP requirements. You will generate COAs, review EM data, and collaborate with stakeholders to maintain timely releases.

The role reports to the Senior Manager of Quality Assurance – Lot Disposition and requires 3–5 years in a QA role and a Bachelor’s degree in life or physical sciences.

Qualifications

• 3–5 years working in a Quality role within a biopharmaceutical or related field.
• Bachelor’s degree in life or physical science or equivalent.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics/cell therapy.
• Detail oriented with strong documentation practices.
• Direct experience with lot disposition and manufacturing, testing, release, and distribution.

Responsibilities

• Perform routine lot disposition for finished products and incoming materials under cGMP.
• Generate, review and approve COA against release specs; ensure EM data are approved.
• Review lot genealogy for raw materials and components used in each drug product lot.
• Perform drug product lot disposition and generate Release For Infusion documentation.
• Create and revise SOPs, WI, forms and reference documents as needed.
• Support audits, CAPAs, change controls and QA department needs.
• Represent QA at project meetings and provide input on quality issues.

Skills

Quality mindset

Documentation

Cross-functional

Communication

cGMP knowledge

Education

Life science degree

Physical science degree

Job description

Bristol Myers Squibb in Bothell, WA seeks a Senior Specialist, Quality Assurance Lot Disposition to ensure final drug products and incoming materials are released to market following cGMP requirements. You will generate COAs, review EM data, and collaborate with stakeholders to maintain timely releases.

The role reports to the Senior Manager of Quality Assurance – Lot Disposition and requires 3–5 years in a QA role and a Bachelor’s degree in life or physical sciences.