Senior Specialist, Quality Assurance Lot Disposition
$92,290–$111,837 year
On-siteBothell, Washington, United States
Job Summary
Conduct routine lot disposition activities for finished drug products and incoming raw materials by ensuring all relevant documentation is accounted for, completed, and approved under cGMP standards. Generate, review, and approve Certificates of Analysis against release specifications, while ensuring EM data are approved and any excursions are documented within a QMS record. Perform the drug product lot disposition process, review lot genealogy for raw materials, and assemble Quality system documents such as deviations and batch production records. Create and revise Standard Operating Procedures and Work Instructions as needed, and support internal and external audit activities, CAPAs, and change controls. Represent the Quality unit at project meetings and act as a subject matter expert for QA oversight during regulatory inspections. Work a Tuesday through Saturday schedule with flexible start times in a typical office environment.
Required Qualifications
- 3-5 years working in a Quality role within a commercial or clinical biopharmaceutical, cellular therapy, or gene therapy organization
- Bachelor's degree in life or physical science discipline or an equivalent combination of education and work experience
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy
- Detail oriented with strong good documentation practices expertise
- Direct experience with lot disposition supporting the manufacturing, testing, disposition, and distribution of cGMP products
- Demonstrated excellence in written and verbal communication
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
- Tuesday - Saturday schedule with flexible starting time to be determined based on team and operational needs
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