QC Associate II

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The Opportunity
Description
We're looking for a QC Associate II, working in 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.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success

Requirements:

• BS Degree in Science (Preferably in Microbiology)
• 2 or more years of experience in cGMP regulated industry (Preferably in QC Microbiology lab)
• 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 experience with Pipetting
• 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

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?