Sr Associate QA I
Scorpion Therapeutics
SR ASSOCIATE QUALITY ASSURANCE (PQA) – NIGHT SHIFT What You Will Do Sr. Associate Plant Quality Assurance (PQA) on-the-floor role supporting bulk drug substance manufacturing and new product introduction across development, clinical, and commercial operations; facilitates real-time decisions to ensure adherence to GMP. Provide coaching/guidance for manufacturing events, deviations, quality systems, and compliance. Responsibilities Quality oversight of new product introduction (facilities, utilities, equipment, systems/process), incl. commissioning/qualification/validation and new documentation. Ensure products are manufactured, tested, stored, and distributed per cGMP, GDP, and applicable regulations. Ensure compliance of facilities/equipment/materials/organization/processes/procedures with cGMP/GDP, safety, and other controls. Drive closure/review/approval of cGMP documents/records incl. deviations, investigations, CAPA, change control, and validations. Ensure production/testing records are complete, accurate, and documented per GDP/cGMP. Oversee on-the-floor analytical testing; assess quality-impacting changes. Ensure deviations are investigated/documented; alert senior management to quality/compliance/supply/safety risks. Provide project management support; identify/implement continuous improvement. Support PQA in audits/inspections; may interact with regulatory agencies. Qualifications Basic High school/GED +4 years; or Associate’s +2 years; or Bachelor’s +6 months in QA, manufacturing, and/or other regulated environment work. Preferred Strong cGMP/GDP; biotech/pharma plant start-up; regulated environment experience; upstream/downstream understanding; Microsoft Office; EBR/MES/Delta V/electronic quality systems; deviations records; GMP testing lab experience; strong organization; written/oral communication; team and independent work. Benefits (if eligible) Health/welfare plans retirement & savings life/disability flexible spending bonus/incentives stock-based long-term incentives time-off plans Application Instructions Apply via careers.amgen.com; no application deadline (accepted until sufficient applications/candidate selected). Sponsorship not guaranteed. #J-18808-Ljbffr Scorpion Therapeutics
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