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 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 is required.

Responsibilities

• Conduct routine lot disposition activities for finished drug products and incoming raw materials ensuring all relevant 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 documented within a QMS record.
• Collaborate with stakeholders and management to communicate lot disposition status, monitor progression, and issue status reports.
• Review lot genealogy for all raw materials and components used in each drug product lot to ensure they are approved and released 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 such as deviations, batch production records, test methods, specifications, and controlled forms for each lot disposition.
• Create and revise SOPs, WI, forms, and reference documents as needed.
• Support internal and external audit activities, CAPAs, change controls, and other QA department needs.
• Champion a positive quality culture aligned with BMS values.
• Support continuous improvement projects to improve efficiency of manufacturing and related processes.
• Represent the Quality unit at project meetings and provide quality input for issue resolution.
• Act as subject matter expert for QA oversight of cGMP operations during audits and regulatory inspections.
• Work environment is office-based; ability to sit, stand, and walk up to 10% as needed.

Qualifications

• 3-5 years in a Quality role within a commercial or clinical biopharmaceutical, cellular therapy, or gene therapy organization.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy.
• Attention to detail with strong good 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.

Skills

• Quality systems and documentation management
• cGMP regulatory knowledge
• Lot disposition and release processes
• Cross-functional collaboration
• Audit and regulatory inspection readiness

Education

Additional Requirements