(USA) Quality Assurance/systems Manager (import, Regional, Returns, Wm.com) - job 1 of 5

This position is responsible for authoring, reviewing, and approving deviations and non-conformances within a biologics manufacturing setting. Strong experience in upstream processes and/or cell/gene therapy. Key Responsibilities: • Deviation and Investigation Writing: Draft 5-7 minor deviations per week with 5-6 approved, or 3-5 major deviations weekly. • Unit Operations Expertise: Including cell culture, bioreactors, TFF, chromatography, and filtrations.• Single-Use Disposable Systems: Experience with these systems.• Root Cause Analysis (RCA): Familiarity with 5 Whys, 6Ms, and fishbone diagrams.• TrackWise System: Experience with TrackWise or similar systems.Must-Have Qualifications:• Upstream and/or Cell/Gene Therapy Experience• Proven Experience in Authoring Deviations/Investigations• Strong Biologics Experience• Familiarity with cGMP Manufacturing Environments• Strong Writing Skills• Life Science or Engineering Degree with at least 5 years of relevant experience