Quality Control Analyst III (Onsite)

Job description

Location: Lynnwood,Washington,United States POSITION SUMMARY: The Quality Control Department is responsible for all testing related to the manufacturing and release of Leukine. These activities include testing raw materials, process intermediates, Drug Substance (DS), Drug Product (DP) and oversight of all contract laboratory testing. Additionally, QC supports microbiological control of the facility/utility systems and the manufacturing environment. This ensures Leukine product will consistently meet the pre-defined standards for patient safety and product quality. PRIMARY RESPONSIBILITIES: LABORATORY TESTING (~75%): - Perform release and stability testing according to SOPs for raw materials, in-process intermediates, BDS and DP - Peer review complex assay documentation to ensure completeness and good documentation practices - Troubleshoot method/equipment issues to find root cause and correct/prevent re-occurrences - Qualify critical reagents, materials, standards and controls to ensure suitable for intended use - Proactively identifies and escalates potential roadblocks. - Investigate and document deviation, determine root cause and product impact to propose corrective/preventive...