QC Associate I (Fremont, CA)
Req : 9724459
Date Start: 02/24/2020
Date End: 07/24/2020
Day to day duties will include but not limited to, 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 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.
Should be able to lift, carry, push or pull up to 50 pounds occasionally.
Assist in revising Standard Operating Procedures.
Perform GMP document reviews as required.
Ensures sampling, testing and release timelines are met.
Follows well-defined and established procedures and best practices.
Demonstrates proficient computer skills i.e. documentation systems, databases and spreadsheets, knowledge of Microsoft applications, must be able to use computers to perform data-entry functions etc.
Demonstrates excellent interpersonal and communication skills both written and oral .
Demonstrates ability to work under minimal direction and as part of a team.
Demonstrates strong attention to detail.
Demonstrates good facilitation, organizational and problem solving skills.
BS Degree in Science Preferably in Microbiology .
Languages: English Read Write Speak
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