Quality Assurance Specialist

Hunter Recruiting; Berkeley (CA); On-site; USD 96,000 - 138,000; Full time

Job summary

Hunter Recruiting is seeking a Quality Assurance Specialist with senior microbiology expertise to support sterility assurance and contamination control. The contract role emphasizes environmental monitoring, personnel monitoring, organism trends, and contamination investigations.

The specialist will operate as an individual contributor, interpreting microbial data within an integrated control strategy and collaborating across QC and QA teams to drive CAPA effectiveness.

Qualifications

• Bachelor's degree in microbiology, biology, biotechnology or related science.
• Minimum 5 years of relevant QC microbiology, environmental monitoring or aseptic manufacturing experience.
• Strong understanding of environmental monitoring, microbial IDs, bioburden and contamination investigations.
• Experience supporting GMP deviations, CAPAs, root‑cause analysis and risk assessments.
• Ability to translate micro data into practical contamination control recommendations and write clear docs.

Responsibilities

• Provide senior microbiology support for environmental monitoring and aseptic processing.
• Review microbial data, assess organism source plausibility, and interpret trends.
• Investigate contamination events, EM excursions and CAPA effectiveness.
• Collaborate with QC Microbiology, QC EMO, and other functions to escalate issues.
• Contribute to site standards, decision trees and technical guidance on contamination control.

Skills

Microbiology

Environmental monitoring

Aseptic technique

GMP compliance

Technical writing

Education

Bachelor's degree in microbiology or related field

Tools

LIMS

MS Office

Job description

The Quality Assurance Specialist will provide senior individual-contributor microbiology and aseptic-processing expertise to support the Sterility Assurance and Contamination Control Program. This contract role will focus on environmental monitoring reports, personnel monitoring, organism trends, microbial contamination investigations, APS/media fill support, microbial risk assessments, and contamination control effectiveness.

The role will help ensure that microbial data and contamination events are interpreted as part of an integrated sterility assurance and contamination control strategy. This position is an individual contributor specialist role and does not include people management responsibilities.

Quality Assurance Specialist 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 related to aseptic processing, cleanroom operations, material transfer, cleaning/disinfection, utilities, interventions, personnel practices, and contamination control gaps.
• Review microbial identification results and support interpretation of organism source plausibility, including human flora, water-associated organisms, spore-formers, environmental organisms, objectionable organisms, and recurring isolates.
• Support investigation of Grade A/B/C/D contamination events, including review of EM data, personnel monitoring, process observations, cleaning history, maintenance activities, material flow, intervention records, and facility/utility conditions.
• Partner with QC Microbiology and QC EMO to identify adverse trends, recurring locations, recurring operators, recurring organisms, and cross-area contamination signals that may require escalation to CCS, QRM, or Site Quality governance.
• Support APS/media fill assessments by evaluating contamination events, intervention representativeness, personnel participation, recurring failure modes, and CAPA effectiveness.
• Assist with development of risk-based escalation criteria for EM/personnel monitoring trends, microbial IDs, contamination-related deviations, and repeat events.
• Review contamination-related deviations and CAPAs, as assigned, to 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 content, and technical guidance related to microbial contamination control.

Quality Assurance Specialist Requirements:

• Bachelor’s degree in microbiology, biology, biotechnology, pharmaceutical sciences, or a related scientific discipline.
• 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.
• 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.
• Strong technical writing and cross-functional communication skills.

Quality Preferred Qualifications:

• Experience with Grade A/B aseptic processing, biologics, cell therapy, sterile drug product, or sterile manufacturing operations.
• Experience with APS/media fills, gowning qualification, operator monitoring, aseptic behavior observations, disinfectant efficacy, cleaning/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.
• Experience with microbial source tracking, recurring organism assessments, objectionable organism rationale, or biofilm-related investigations.
• Experience working with QC Microbiology, Manufacturing, QA, Engineering, and Validation teams.