QC Associate II

Description

We're looking for a QC Associate II , working in the Pharmaceuticals and Medical Products industry in 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.