Senior Microbiology QA Specialist: Sterility & Contamination

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

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.