Lead and execute laboratory investigations for OOS/OOT, deviations, and atypical results for parenteral products. Perform root cause analysis, review analytical and manufacturing data, prepare investigation reports and CAPAs, support audits/inspections, and drive continuous improvement while ensuring cGMP and data integrity compliance.
The Laboratory Investigations Scientist is responsible for conducting, documenting, and supporting investigations related to deviations, out-of-specification (OOS) results, and non-conformances associated with the testing and manufacturing of parenteral (sterile injectable) products. This role ensures compliance with cGMP regulations while supporting root cause analysis and implementing corrective and preventive actions (CAPA).
Key Responsibilities:
- Lead and support laboratory investigations for OOS, OOT (Out of Trend), deviations, and atypical results related to parenteral products.
- Perform root cause analysis using structured methodologies (e.g., fishbone diagrams, 5 Whys).
- Review analytical data, laboratory documentation, and manufacturing records to identify discrepancies.
- Collaborate with Quality Assurance, Manufacturing, Microbiology, and Analytical teams to support investigations.
- Ensure investigations are completed in a timely manner and in compliance with cGMP, FDA, and regulatory requirements.
- Prepare detailed investigation reports, including conclusions and recommended CAPAs.
- Support implementation and effectiveness checks of CAPAs.
- Participate in audit readiness activities and support inspections as needed.
- Identify opportunities for continuous improvement in laboratory processes and investigation practices.
- Maintain proper documentation practices in compliance with data integrity requirements (ALCOA principles).
Requirements
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