Senior Scientist, QC Compliance

Role: Senior Scientist specializing in QC compliance, leading the authoring and management of QC deviations, laboratory investigations, CAPAs, and change controls. Responsibilities include conducting root cause analysis on complex investigations, ensuring timely and compliant closure of quality issues, generating KPIs, and representing the department during inspections. The role involves owning document revisions, cross-functional communication, and mentoring team members. Requirements: Bachelor's degree in science, engineering, or related discipline; 8+ years in biopharmaceutical or QC lab operations with at least 2 years of investigation experience; strong knowledge of cGMP, regulatory requirements, and technical writing skills. Preferred qualifications include advanced degrees and experience with analytical/microbiological testing, quality systems, and investigations. High-value specifics: Focus on biopharma QC, investigations, deviations, CAPAs, and regulatory interactions; role may support authoring responses for inspections and internal audits. The position is based in Bothell, WA, with a focus on GxP compliance, laboratory investigations, and quality management systems.