Job Details

Sterility Assurance Specialist

  2026-09-20     KellyMitchell Group     Berkeley,CA  
Description:

Job Summary Our client, a leading Healthcare & Life Sciences provider, is seeking a Sterility Assurance Specialist to join their team! This position will report onsite at our client's Berkeley, CA location. The ideal candidate will possess skills in microbiological risk interpretation, aseptic processing awareness, pattern recognition/trend assessment, and root cause thinking. This position is W-2 only. We do not work with third-party firms or C2C arrangements for this role.Core Responsibilities Provide senior individual contributor microbiology and aseptic processing expertise to support Site Sterility Assurance and Contamination Control ProgramFocus on environmental monitoring reports, personnel monitoring, organism trends, microbial contamination investigations, APS/media fill support, microbial risk assessments, and contamination control effectivenessHelp ensure that microbial data and contamination events are interpreted as part of an integrated sterility assurance and contamination control strategyRequired Skills/Experience (Must-Haves) Bachelor's degree in microbiology, biology, biotechnology, pharmaceutical sciences, or a related scientific discipline5+years of relevant experience in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, contamination control, sterility assurance, or biologics/cell therapy manufacturingStrong understanding of environmental monitoring, personnel monitoring, microbial identification, bioburden, aseptic technique, cleanroom controls, and contamination investigationsExperience supporting GMP deviations, CAPAs, root cause analysis, risk assessments, and technical documentationAbility to interpret microbial data and translate findings into practical contamination control recommendationsWork Environment Location: Berkeley, CA Hybrid/Onsite 9am PST Start TimeCompensation & Benefits Pay Range: The approximate pay range for this position is between $35.00 to $50.00 per hour. Please note that the pay range provided is a good faith estimate. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and location. We comply with local wage minimums.Medical, Dental, & Vision Insurance PlansEmployee-Owned Profit Sharing (ESOP)401K offeredAbout KellyMitchell At KellyMitchell, our culture is world class. We're movers and shakers! We don't mind a bit of friendly competition, and we reward hard work with unlimited potential for growth. This is an exciting opportunity to join a company known for innovative solutions and unsurpassed customer service. We're passionate about helping companies solve their biggest IT staffing & project solutions challenges. As an employee-owned, women-led organization serving Fortune 500 companies nationwide, we deliver expert service at a moment's notice.#J-18808-Ljbffr


Apply for this Job

Please use the APPLY HERE link below to view additional details and application instructions.

Apply Here

Back to Search