Microbiologist Ii
Current- Cleanroom/gowning qualified and complies with annual gowning qualification- Performed visual inspection of microbiological, EM samples and media fill units.- Performed environmental monitoring of TPI-controlled and aseptic manufacturing areas.- Collected samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles.- Completed routine monitoring for water for injection (WFI), reverse osmosis (RO), purifies water (PW), and clean steam (CS) systems.- Executed bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples.- Incubated viable samples and performed tests for bioburden and microbial limit- Reviewed microbiology laboratory data and completed data entry of results in Excel for trend analysis