Specialist Manufacturing Investigations

Role: Investigations Specialist within biopharma manufacturing, focusing on deviation management in biologics drug substance production at Amgen's NC facility. Responsibilities: lead root cause analysis for major deviations, coordinate cross-functional investigation teams, ensure regulatory compliance, develop CAPAs, and improve investigation processes. Present findings to inspectors and internal stakeholders, effectively communicate investigation status, and foster collaboration. Requirements: Doctorate or Master’s with 2+ years, Bachelor’s with 4+ years, or equivalent experience in biotech/pharma manufacturing, process development, or quality assurance; strong problem-solving and root cause analysis skills; experience with Veeva QMS preferred. High-value specifics: biologics drug substance, manufacturing investigations, compliance and quality systems, complex root cause analysis tools, regulatory inspection experience, and project management. Work setup: likely hybrid with potential remote work; no explicit travel mentioned.