Sterility Assurance Specialist

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

Sterility Assurance Specialist (Contract)

Type: Contract — up to $56/hr

Duration: 12–18 months, with extension or conversion possible

About the Role

Our client, a global life sciences manufacturer, is seeking a Sterility Assurance Specialist to support its site sterility assurance and contamination control program. This is an individual contributor role — no direct reports — reporting to the site's Contamination Control / Sterility Assurance Lead.

You will be the person who reads the microbial data and says what it means. Environmental and personnel monitoring excursions, recurring organisms, bioburden events, media fill contamination, cross-area signals — the work is interpreting these as one connected picture rather than closing them out one deviation at a time, and turning that reading into contamination control decisions the site will act on

.

Three things are firm on this one. The work is investigative — reading and writing up what the microbial data is telling you, not running the sampling plan. A bachelor's degree in a scientific discipline is a hard requirement. And the job is onsite five days a week.

Key Responsibilities

• Provide technical support for assessment of microbial contamination events, EM excursions, personnel monitoring recoveries, bioburden events, sterility assurance signals, and recurring organism patterns
• Perform microbiological risk assessments covering aseptic processing, cleanroom operations, material transfer, cleaning and disinfection, utilities, interventions, personnel practices, and contamination control gaps
• Review microbial identification results and interpret organism source plausibility — human flora, water-associated organisms, spore-formers, environmental and objectionable organisms, and recurring isolates
• Support investigation of Grade A/B/C/D contamination events across EM data, personnel monitoring, process observations, cleaning history, maintenance activity, material flow, intervention records, and facility and utility conditions
• Partner with QC Microbiology and the environmental monitoring group to identify adverse trends, recurring locations, recurring operators, recurring organisms, and cross-area contamination signals requiring escalation to the contamination control strategy, quality risk management, or site quality governance
• Support APS / media fill assessments — contamination events, intervention representativeness, personnel participation, recurring failure modes, and CAPA effectiveness
• Help develop risk-based escalation criteria for EM and personnel monitoring trends, microbial IDs, contamination-related deviations, and repeat events
• Review contamination-related deviations and CAPAs to provide microbiological rationale, root cause input, risk impact assessment, and effectiveness‑check recommendations
• Contribute to periodic sterility assurance health summaries covering microbial risk signals, repeat contamination patterns, investigation quality, and CAPA effectiveness
• Support development of site standards, decision trees, training content, and technical guidance for microbial contamination control

Required Qualifications

• Bachelor's degree or higher in microbiology, biology, biotechnology, pharmaceutical sciences, or a related scientific discipline — this is a hard requirement and relevant experience does not substitute
• 5+ years in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, contamination control, sterility assurance, or biologics / cell therapy manufacturing
• Strong working knowledge 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
• Strong technical writing and cross‑functional communication skills
• Able to work onsite in Berkeley, CA five days per week

Preferred

• Grade A/B aseptic processing in biologics, cell therapy, or sterile drug product operations
• APS / media fills, gowning qualification, operator monitoring, aseptic behavior observations, disinfectant efficacy, cleaning and disinfection programs, or contamination recovery investigations
• Familiarity with EU GMP Annex 1, FDA aseptic processing guidance, USP microbiology chapters, PDA technical reports, and ICH Q9/Q10
• Microbial source tracking, recurring organism assessments, objectionable organism rationale, or biofilm‑related investigations
• Working across QC Microbiology, Manufacturing, QA, Engineering, and Validation teams

Benefits (employee contribution)

• Health insurance
• Health savings account
• Vision insurance
• Flexible spending accounts
• Life insurance

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualifications of the applicant.