Found Description
What you'll do
- Perform microbiological testing (bioburden, LAL, plating/counting, microbial identification, EM sampling, particulate monitoring).
- Conduct environmental monitoring (air, surface, viable, and non-viable sampling) across manufacturing and cleanroom areas.
- Analyze raw materials, in-process, environmental, and final product samples per SOPs and GMP requirements.
- Document, review, and report results in compliance with cGMP and data integrity standards.
- Support trending, investigation, and deviation/OOS activities, including root cause analysis.
- Maintain laboratory operations (equipment upkeep, housekeeping, reagents, consumables, and inventory control).
- Manage sample logistics including retention samples, external testing coordination, and QC documentation/shipping.
- Prepare and maintain GMP-compliant standards and reagents.
- Ensure timely testing and repo...
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