QC Associate Scientist - Bioassay - Site Based, Redmond, WA

Role Summary

QC Associate Scientist - Bioassay to join our team in Redmond, WA. You will perform QC analysis supporting GMP manufacturing activities for biotherapeutic products, collaborate with Analytical Development, and contribute to documentation, investigations, and continuous improvement of QC processes.

Responsibilities

• Perform routine/non-routine QC testing using techniques such as cell-based assays, ELISA, and qPCR.
• Ensure timely and accurate completion of GMP documentation.
• Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for qualification and transfer of analytical methods.
• Conduct laboratory investigations, deviations, OOS, change controls and CAPAs.
• Support equipment qualification (IQ, OQ, PQ).
• Create, maintain, and revise SOPs, methods and associated documents.
• Support all operations of the QC labs including ordering supplies and maintaining laboratory equipment and spaces.
• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on analytical matters.
• Participate in daily and weekly operation meetings.

Qualifications

• Required: Bachelor‚Äôs degree in Biochemistry, molecular/cellular biology, or chemistry with 3+ years related field experience; GMP experience preferred.
• Preferred: Laboratory experience with potency and/or impurity methods (e.g., cell-based assays, immunoassays, qPCR).
• High attention to detail and organization.
• Experience with Microsoft Office apps (Word, Excel, PowerPoint).