Quality Investigator, Pharma CAPA & GMP
Overview
You will own site investigations and CAPA execution in an FDA-regulated environment, driving minor, major, and critical exceptions to closure. 3-5 years of experience in pharmaceutical or biological settings is required, with deep GMP knowledge. You will collaborate with Operations, Quality, Engineering, and Supply Chain to ensure compliance across the plant. This role offers direct audit support and root cause ownership, where your judgment shapes sustainable corrective actions.
What You'll Do8
- 1Investigate minor, major, and critical exceptions, using SAP and GMP principles to document root cause and CAPAs.
- 2Lead Phase II Out-of-Specification (OOS) investigations, applying CAPA methodology to prevent recurrence.
- 3Support external audits by preparing documentation, acting as a Scribe, and performing pre-review with cGMP standards.
- 4Track and report investigation progress to management weekly, ensuring actions close within deadlines.
- 5Compile data for Annual Product Reviews (APRs) and trend Quality Metrics like Cost of Poor Quality and KPIs.
- 6Revise Standard Operating Procedures (SOPs) to reflect current GMP and process changes.
- 7Prepare GEMBA plans and conduct plant walks to drive compliance and safety improvements.
- 8Collaborate with cross-functional teams to gather evidence and drive investigations to completion.
Requirements8
- 13-5 years in pharmaceutical, biological, or FDA-regulated industries.
- 2Hands-on experience with CAPA, OOS, and GMP investigations.
- 3Proficiency in SAP for tracking and data integrity.
- 4Strong skills in MS Office (Word, Excel, Outlook) for documentation.
- 5Bachelor's degree in Chemistry, Microbiology, Biology, or Engineering preferred; experience may substitute.
- 6Working knowledge of FDA regulations and cGMP requirements.
- 7Excellent written and verbal communication for cross-functional coordination.
- 8Detail-oriented with ability to work independently and in teams.
Salary Insight
$104 - $108k per year
Location
Required Skills
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