Job Summary:
The QC Investigation Writer leads and documents laboratory investigations in a GMP-regulated pharmaceutical, biotechnology, or biologics environment. The role focuses on identifying root causes, assessing product impact, ensuring regulatory compliance, and developing effective CAPAs.
Key Responsibilities:
- Author and lead OOS, OOT, Environmental Monitoring (EM), and laboratory deviation investigations.
- Review analytical and microbiological data to determine root causes and product impact.
- Prepare investigation reports, CAPAs, deviations, and change controls.
- Ensure compliance with FDA regulations, cGMP requirements, and data integrity standards.
- Collaborate with QC, QA, Microbiology, and Manufacturing teams.
- Support audits, regulatory inspections, and continuous improvement initiatives.
Qualifications:
- Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a related field.
- Minimum 2 years of GMP-regulated industry experience.
- Experience writing laboratory investigations, including OOS/OOT, deviations, and CAPAs.
- Strong technical writing, root cause analysis, and regulatory compliance knowledge.
- Experience with TrackWise or other electronic Quality Management Systems preferred.
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