Senior Specialist – Investigations & Regulatory Inspections
About this role
About the Role Amgen's Senior Specialist – Investigations & Regulatory Inspections will be a key member of the North Carolina Biologics Drug Substance Manufacturing plant team, helping to investigate major deviations, coordinate regulatory interactions, and drive inspection readiness for inspections and internal audits. The role supports the FleX Batch facility’s aim to combine advanced single-use and stainless steel technologies with sustainability goals as Amgen works toward carbon neutrality by 2027. What You'll Do
- Manage the site's most complex major deviation investigations, including assembling investigation teams, leading advanced root cause analysis, development of CAPAs, and compliant documentation of findings.
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