6397 Kaiser Drive, Fremont, California, 94555, United States .
Job description:
LAL (Endotoxin) and Bioburden testing of in-process samples, raw materials, equipment rinses, WFI and bulk drug substance. Bioburden testing using Membrane Filtration method and Pour plate method. Biological indicator (BI) testing for autoclave validation. Gram staining, and microbial identification of Environmental Monitoring samples, and In Process Testing samples. Growth promotion testing and release of microbiological media. Assist in the preparation of periodic trend reports and analysis of microbiological data. Assist in laboratory investigations of microbiology excursions. Enter data in QC LIMS or other databases in a timely manner. Perform other miscellaneous Lab maintenance activities.
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