QC Associate I
6397 Kaiser Drive Fremont, CA 94555 US
Minimum Education / Experience: BS Degree in Science (Preferably in Microbiology) Years of Experience: 1+ years of experience in cGMP regulated industry or equivalent college experience preferred.
This position require flexibility in the working hours in the weekends if needed.
Day to day duties will include but not limited to: • Collect routine Environmental Monitoring and Utility samples from Manufacturing plant • Perform LAL and Bioburden testing of environmental monitoring samples, in-process samples, raw materials, equipment rinses and bulk drug substance using Chromogenic, and Turbidimetric method and Membrane Filtration, and Pour plate method, respectively. • Perform growth promotion testing of microbiological media. • Assist in writing periodic trend reports and analysis of microbiological data. • Perform laboratory investigations of microbiology excursions. • Enter data in LIMS or other databases in a timely manner. • Other miscellaneous Lab maintenance activities. • Should be able to lift, carry, push or pull up to 50 pounds occasionally. • Assist in revising and creating Standard Operating Procedures. • Perform document review as required. Other: • 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 • Must have working knowledge of relevant Standard Operating Procedures, U.S. and E.U. Good Manufacturing Procedures and other regulatory requirements • Must be able to work flexible hours including weekends, if needed.