Sterility Assurance Specialist — Onsite, Berkeley (Contract)

Stockell Consulting, LLC.; Berkeley (CA); On-site; USD 64,000 - 91,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Vision insurance

Flexible spending accounts

Life insurance

Job summary

Stockell Consulting, LLC. seeks a Sterility Assurance Specialist to support its site sterility program in Berkeley.

You will read microbial data and translate findings into actionable contamination control decisions, focusing on EM excursions, bioburden events, and recurring patterns. The role requires a Bachelor's in a scientific discipline and is onsite five days a week, with a 12–18 month contract duration and extension potential.

Qualifications

• Bachelor's degree or higher in a scientific discipline (microbiology, biology, biotech, pharma)
• 5+ years in QC Microbiology, environmental monitoring, aseptic processing, or related fields
• Strong knowledge of environmental monitoring, microbial identification, bioburden, aseptic technique, cleanroom controls
• Experience supporting GMP deviations, CAPAs, risk assessments, and technical documentation
• Ability to translate microbial data into practical contamination control recommendations
• Strong writing and cross-functional communication skills
• Onsite work in Berkeley, CA five days per week

Responsibilities

• Provide technical support for assessment of microbial contamination events, EM excursions, bioburden events, and recurring organism patterns
• Perform microbiological risk assessments across aseptic processing, cleanrooms, cleaning and disinfection, utilities, and containment gaps
• Review microbial identification results and interpret source plausibility (human flora, water organisms, spore-formers)
• Support investigations of contamination events across EM data, personnel monitoring, and facility conditions
• Collaborate with QC Microbiology and EM groups to identify adverse trends and escalation signals
• Support media fill assessments and CAPA effectiveness
• Develop risk-based escalation criteria for EM and personnel trends and microbial IDs
• Review CAPAs for microbiological rationale, root cause input, and risk assessment
• Contribute to sterility assurance health summaries and site standards

Skills

Microbiology

Environmental monitoring

Data interpretation

Technical writing

Cross-functional communication

Education

Bachelor's degree (microbiology or related)

Job description

Stockell Consulting, LLC. seeks a Sterility Assurance Specialist to support its site sterility program in Berkeley.

You will read microbial data and translate findings into actionable contamination control decisions, focusing on EM excursions, bioburden events, and recurring patterns. The role requires a Bachelor's in a scientific discipline and is onsite five days a week, with a 12–18 month contract duration and extension potential.