- Execute routine EV sampling across classified cleanroom areas, including active/passive air sampling, settle plates, surface swabs, and personnel monitoring.
- Monitor critical room parameters such as temperature, relative humidity, and differential pressure gradients.
- Perform water sampling and microbiological/chemical analysis of raw, purified, and Water-for-Injection (WFI) systems.
- Report and document any Out of Specification (OOS) or Out of Trend (OOT) data observed during environmental monitoring.
- Conduct Microbial Limit Tests (MLT), Bioburden testing, and specific pathogen screening on raw materials, in-process batches, and finished products.
- Perform routine Sterility Analysis on finished sterile lots and product components under aseptic conditions.
- Execute Bacterial Endotoxin Tests (BET) and Growth Promotion Testing (GPT) on media lots to ensure nutritional viability.