OOS Writer

Job Description
We’re seeking an experienced Investigator – Exceptions / OOS Writer to support Quality operations in a regulated pharmaceutical manufacturing environment. This role is responsible for leading and authoring deviation, exception, and OOS investigations, ensuring timely, thorough, and compliant documentation in accordance with cGMP and regulatory expectations. The ideal candidate is detail-oriented, analytical, and comfortable working cross-functionally in a fast-paced quality organization.
Location & Schedule

Raleigh, NC (on-site)
Shift and overtime requirements may vary based on production and investigation needs

Key Responsibilities

Lead and author deviations, exceptions, OOS, and OOT investigations from initiation through closure
Perform root cause analysis and define effective CAPAs
Ensure investigations are thorough, scientifically sound, and inspection-ready
Collaborate with QC, Manufacturing, Engineering, and Quality tea...

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