Senior Specialist, Quality Assurance Lot Disposition

Role Summary

The Senior Specialist, Quality Assurance Lot Disposition is a full-time role at the Bristol Myers Squibb Bothell, WA Cell Therapy manufacturing site. The primary focus is to ensure final drug products and incoming raw materials are released to market following all internal procedures and cGMP requirements. Reports to the Senior Manager of Quality Assurance - Lot Disposition. Work Shift: 4 x 10hrs / Day; weekend and holiday work required.

Responsibilities

• Conduct routine lot disposition activities for finished drug products and incoming raw materials, ensuring all lot documentation is accounted for, completed, and approved under cGMP standards.
• Generate, review, and approve the Certificate of Analysis against release specifications; ensure EM data are approved and excursions are documented within a QMS record.
• Collaborate with stakeholders and management; communicate lot disposition status and issue status reports.
• Review lot genealogy for all raw materials and components used in each drug product lot; ensure approval and release using MES or ERP systems.
• Perform the drug product lot disposition process and generate, review, and approve Release For Infusion (RFI) documentation.
• Assemble and review Quality system documents (deviations, batch production records, test methods, specifications, and controlled forms) associated with each lot for disposition.
• Create and revise SOPs, WI, forms, and reference documents as needed.
• Support internal and external audits, CAPAs, change controls, and other QA needs as identified by management.
• Champion and foster a positive quality culture; support continuous improvement projects to improve efficiency of manufacturing and related processes.
• Represent the Quality unit at project meetings; provide quality input in resolution of quality-related issues.
• Act as subject matter expert for QA oversight of cGMP operations during audits and regulatory inspections.
• Work environment: typical office setting; some standing/walking up to 10%; standard conditions.

Qualifications

• 3-5 years of Quality experience in a commercial or clinical biopharmaceutical, cellular therapy, or gene therapy organization.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy.
• Detail-oriented with strong documentation practices.
• Direct experience with lot disposition supporting manufacturing, testing, disposition, and distribution of cGMP products.
• Excellent written and verbal communication; ability to work cross-functionally and build relationships.