Sterility Assurance Specialist

Harvestaff; Berkeley (CA); On-site; USD 101,000 - 117,000; Part time

Job summary

Harvestaff is seeking a Sterility Assurance Specialist in Berkeley, CA. This senior individual contributor role focuses on microbiology, aseptic processing, environmental and personnel monitoring, and CAPA effectiveness to support sterility assurance programs.

The candidate will review microbial identifications, investigate contamination events, and collaborate with QC Microbiology, Manufacturing, Quality Assurance, Engineering, and Validation teams.

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• Familiarity with EU GMP Annex 1, FDA aseptic processing guidance, USP microbiology chapters, PDA technical reports, and ICH Q9/Q10.

Responsibilities

• Provide technical support for microbial contamination events and environmental monitoring excursions.
• Perform microbiological risk assessments related to aseptic processing and cleanroom operations.
• Review microbial identification results and assess potential organism sources.
• Support investigations of Grade A/B/C/D contamination events.
• Review environmental monitoring data and facility conditions during investigations.
• Collaborate with QC Microbiology, QC Environmental Monitoring, and other teams to identify adverse trends.
• Support media fill assessments and CAPA effectiveness evaluations.
• Assist in developing risk-based escalation criteria for monitoring trends and contamination events.
• Review deviations and CAPAs with microbiological rationale and risk impact assessments.
• Contribute to Sterility Assurance health summaries and regulatory guidance development.
• Collaborate with QC Microbiology, Manufacturing, QA, Engineering, and Validation teams.
• Report to the Site Contamination Control/Sterility Assurance Lead.

Skills

QC Microbiology

Environmental Monitoring

Aseptic Processing

Contamination Control

Sterility Assurance

Biologics Manufacturing

CAPA & Root Cause

Technical Writing

Cross-functional Collaboration

Education

Bachelor’s degree in Microbiology/ Biology/ Biotechnology/ Pharmaceutical Sciences

EU GMP Annex 1 / FDA guidance familiarity

Job description

Sterility Assurance Specialist

JOB-10047599

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.

Job Summary

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.

Job Description

• 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.

Skills Required

• 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 assessments, objectionable organism rationale, or biofilm-related investigations is preferred.
• Strong understanding of environmental monitoring and personnel monitoring.
• Knowledge of microbial identification, bioburden, aseptic techniques, cleanroom controls, and contamination investigations.
• Experience with 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 microbiological risk interpretation and trend assessment skills.
• Strong root cause analysis and problem-solving skills.
• Knowledge of quality risk management principles.
• Strong technical writing and cross-functional communication skills.
• Practical judgment in contamination control and sterility assurance.
• Ability to recognize microbial patterns, recurring organisms, and contamination trends.
• Ability to influence cross-functional teams as a senior individual contributor.

Education/Training/Certifications

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.
• Familiarity with EU GMP Annex 1, FDA aseptic processing guidance, USP microbiology chapters, PDA technical reports, and ICH Q9/Q10.

Additional Requirements

• Must be able to pass drug screenings and criminal background checks
• Start Time: 09:00 AM
• Contract duration: 12–18 months, with potential extension based on program needs and deliverables.

Pay Rate/Salary

• Estimated Salary: $48.45 to $56.45per hour. Compensation will be offered within this posted range based on experience, skills, and market factors.

Equal Opportunity

HarveStaff LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.