- Ensure adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice).
- Monitor laboratory environment, including temperature, cleanliness, and fumigation, ensuring timely data entry.
- Perform analyses in accordance with product specifications.
- Manage sample receipt, logging, and segregation, generating analytical reference numbers.
- Follow testing schedules, conduct material testing (In process, finished products, and stability) with quality and compliance, and update testing status.
- Process and aliquot samples in the Molecular Biology laboratory.
- Reconcile and discard samples post-testing and review.
- Generate and maintain analytical records.
- Execute and validate analytical method transfers.
- Review analytical test reports (In process, finished products, and stability).
- Maintain and calibrate equipment/pipettes with the maintenance and instrumentation department.
- Ensure cleanliness and orderliness of workbenches, instruments, logbooks, and documents.
- Report malfunctions and requisition chemicals/reagents/inventory timely.
- Report procedural gaps and unsafe conditions.
- Implement EHS management system effectively.
- Log QMS elements (incidents, change controls, deviations, CAPAs) in Molecular Biology.
- Prepare and revise SOPs, specifications, and technical documents.
- Store reserve samples for in-process stages of various products.
- Conduct and review training on documentation and methods pertinent to the molecular biology laboratory.
Secondary Responsibilities (Where applicable):
- Maintain COA and MSDS for chemicals in the lab.
- Coordinate with Material Management for shipment of samples or reagents.