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Laboratory Scientist
3 weeks ago
We are seeking an experienced Laboratory Scientist to execute microbiological testing and monitoring activities ensuring product and process compliance with established quality standards.
Key Responsibilities- Perform routine microbiological assays including environmental monitoring, sterility testing, bioburden analysis, and growth promotion quality (GPQ) assessments.
- Ensure timely and accurate completion of documentation and data entry for routine laboratory tests to meet defined testing cycle times.
- Facilitate training and qualification of microbiological techniques for laboratory personnel.
- Draft and implement new protocols or revise existing procedures to align with regulatory and internal requirements.
- Conduct validation activities for laboratory processes and instrument qualifications, as applicable.
- Review and approve laboratory test reports, data results, and associated documentation within the Laboratory Information Management System (LIMS).
- Lead investigations into laboratory deviations and non-conformances, including out-of-specification (OOS) results, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPA).
- Serve as a Subject Matter Expert (SME) during cross-functional investigations, regulatory inspections, and internal audits.
- Contribute to the development and optimization of laboratory systems and workflows, including gap analyses and process improvements.
- Participate in Continuous Improvement (CI) initiatives to enhance laboratory efficiency and compliance.
- Maintain strict adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Perform periodic analysis and trending of microbiological data to identify patterns and support decision-making.
- Prepare clear and concise reports, emails, and memos for internal and external stakeholders.
- Ensure laboratory readiness for regulatory inspections and customer audits.
- Uphold a safe laboratory environment by complying with all applicable safety standards and regulations.
- Bachelor's degree in Microbiology, Biology, or a related scientific discipline.
- 3–5 years of relevant experience in the pharmaceutical industry.
- Prior experience in aseptic processing is advantageous.
