Sterility Assurance Specialist

KellyMitchell Group; Berkeley (CA); On-site; USD 48,000 - 69,000; Full time

Benefits offered by this job

Medical, Dental, & Vision Insurance

Employee-Owned Profit Sharing (ESOP)

401K offered

Job summary

KellyMitchell Group is seeking a Sterility Assurance Specialist for a leading Healthcare & Life Sciences provider in Berkeley, CA. The role is onsite with hybrid flexibility and 9am PST start.

The candidate should have a Bachelor’s in a related science and 5+ years in QC Microbiology, environmental monitoring, aseptic processing, or contamination control, with strong data interpretation and documentation skills.

Qualifications

• Bachelor’s degree in microbiology, biology, biotechnology, pharmaceutical sciences, or related field.
• 5+ years of experience in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, or contamination control.
• Strong understanding of environmental/personal monitoring, bioburden, aseptic technique, and contamination investigations.
• Experience supporting GMP deviations, CAPAs, root cause analysis, risk assessments, and technical documentation.

Responsibilities

• Provide microbiology and aseptic processing expertise to support Site Sterility Assurance and Contamination Control.
• Focus on environmental monitoring reports, personnel monitoring, organism trends, and contamination investigations.
• Help ensure microbial data and contamination events are interpreted within an integrated sterility strategy.

Skills

Sterility assurance

Environmental monitoring

Aseptic processing

Root cause analysis

Data interpretation

Education

Bachelor’s degree in microbiology or related scientific discipline

Job 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 Program
• Focus on environmental monitoring reports, personnel monitoring, organism trends, microbial contamination investigations, APS/media fill support, microbial risk assessments, and contamination control effectiveness
• Help ensure that microbial data and contamination events are interpreted as part of an integrated sterility assurance and contamination control strategy

Required Skills/Experience (Must-Haves)

• Bachelor’s degree in microbiology, biology, biotechnology, pharmaceutical sciences, or a related scientific discipline
• 5+years of relevant experience in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, contamination control, sterility assurance, or biologics/cell therapy manufacturing
• Strong understanding of environmental monitoring, personnel monitoring, microbial identification, bioburden, aseptic technique, cleanroom controls, and contamination investigations
• Experience supporting GMP deviations, CAPAs, root cause analysis, risk assessments, and technical documentation
• Ability to interpret microbial data and translate findings into practical contamination control recommendations

Work Environment

Location: Berkeley, CA Hybrid/Onsite 9am PST Start Time

Compensation & 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 Plans
• Employee-Owned Profit Sharing (ESOP)
• 401K offered

About 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.