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 investig...