Sterility Assurance Specialist

Sterility Assurance Specialist

JOB-

Anticipated Start Date

October 5, 20226

Location

Berkeley, CA

Type of Employment

Contract

Employer Info

As a global leader in agriculture enterprise, our client is recognized for their multiple brands and renowned reputation. Their research and development teams combine knowledge and ingenuity to create the most innovative ideas. With their cutting-edge products, they have a common goal: improved quality of life for all.

If you're interested in a Sterility Assurance Specialist job, then this is the best role for you! The Sterility Assurance Specialist provides microbiology and aseptic processing expertise to support sterility assurance and contamination control programs. The role focuses on environmental and personnel monitoring, microbial trends, contamination investigations, media fills, risk assessments, and contamination control effectiveness. This is a senior individual contributor role with no direct people management responsibilities.

• Provide technical support for microbial contamination events, environmental monitoring excursions, personnel monitoring recoveries, bioburden events, and recurring organism patterns.
• Perform microbiological risk assessments related to aseptic processing, cleanroom operations, material transfer, cleaning and disinfection, utilities, interventions, personnel practices, and contamination control gaps.
• Review microbial identification results and assess potential organism sources, including human flora, water-associated organisms, spore-formers, environmental organisms, and objectionable organisms.
• Support investigations of Grade A/B/C/D contamination events.
• Review environmental monitoring data, personnel monitoring, process observations, cleaning history, maintenance activities, material flow, intervention records, and facility or utility conditions during investigations.
• Partner with QC Microbiology and QC Environmental Monitoring teams to identify adverse trends, recurring locations, operators, organisms, and cross-area contamination signals.
• Support APS/media fill assessments by evaluating contamination events, intervention representativeness, personnel participation, recurring failure modes, and CAPA effectiveness.
• Assist in developing risk-based escalation criteria for environmental and personnel monitoring trends, microbial identifications, contamination-related deviations, and repeat events.
• Review contamination-related deviations and CAPAs and provide microbiological rationale, root cause assessment input, risk impact assessment, and effectiveness-check recommendations.
• Contribute to periodic Sterility Assurance health summaries by assessing microbial risk signals, repeat contamination patterns, investigation quality, and CAPA effectiveness.
• Support development of site standards, decision trees, training materials, and technical guidance related to microbial contamination control.
• Collaborate with QC Microbiology, Manufacturing, Quality Assurance, Engineering, and Validation teams.
• Report to the Site Contamination Control/Sterility Assurance Lead.

• Minimum 5 years of relevant experience in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, contamination control, sterility assurance, or biologics/cell therapy manufacturing.
• Experience with Grade A/B aseptic processing, biologics, cell therapy, sterile drug products, or sterile manufacturing operations is preferred.
• Experience with APS/media fills, gowning qualification, operator monitoring, aseptic behavior observations, disinfectant efficacy, cleaning/disinfection programs, or contamination recovery investigations is preferred.
• Experience with microbial source tracking, recurring organism…