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QA & Qc - Microbiology
2 weeks ago
- To establish analytical lab procedures, policies and safety regulations
- Maintain laboratory records to ensure accuracy and compliance
- conduct laboratory test, results and documentation
- Assist In method validation for sterility, bioburden, arid endotoxin of Medical devices, drug and Polymer-based products
- Perform and/or assist in Investigations related to sterility assurance and environmental monitoring.
- Perform routine analysis of the finished product and raw material according to established specifications and procedures relating to Sterility, Bioburden, Endotoxin, Antimicrobial Effectiveness Testing (AET)/Preservative Efficacy Testing (PET) and Growth Promotion.
- Perform atypical particulate inspection on the finished product
- Support sampling and microbiological testing on facility water (WFI, CS, etc.)
- Review and approve data related to sterility, bloburden, AET, and endotoxin testing of finished products and/or raw materials.
- Perform technical review of test results for completeness and compliance to cGMP to ensure that documentation, controls, and traceability are in place to maintain integrity.
- Prepare and review the preparation of media, reagents, test samples, and equipment as required.
- Prepare microorganisms for identification.
- Assist in setting up lab
Ami Polymer
