Senior Scientist, QC Compliance

Role: Senior Scientist leading QC compliance, specializing in laboratory investigations, deviations, CAPAs, change controls, and regulatory inspections. Responsibilities: authoring and managing investigations, root cause analysis, ensuring timely closure of quality issues, generating KPIs, and representing QC during inspections; mentoring team members and supporting continuous improvement projects. Requirements: Bachelor's in science or engineering (advanced degree preferred); 8+ years in biopharma QC operations; extensive experience with regulatory requirements, GxP, and quality systems; strong technical writing and investigation skills; ability to communicate effectively and work in fast-paced environments. Preferred: knowledge of analytical/microbiological testing; experience with investigations and root cause analysis techniques. High-Value: expertise in biopharmaceutical QC, regulatory inspections, investigation management, and quality compliance within biologics or small molecule manufacturing environments. Work Setup: based in Bothell, WA; details on remote or onsite work not specified.