Sterility Assurance Microbiology Specialist

Dexian; Berkeley (CA); On-site; USD 69,000 - 72,000; Full time

Job summary

Dexian is seeking a Sterility Assurance specialist to provide microbiology expertise for Berkeley's contamination control program. Focus areas include environmental monitoring, organism trends, and aseptic processing support, with an emphasis on data interpretation and CAPA effectiveness.

The role is an individual contributor, reporting to the Site Contamination Control/ Sterility Assurance Lead, with a 12–18 month contract and potential extension based on program needs.

Qualifications

• Bachelor’s degree in microbiology or related field.
• 5+ years in QC microbiology and contamination control.
• Strong lab knowledge: environmental monitoring and aseptic processing.
• Experience with GMP deviations, CAPAs, root-cause analysis.
• Ability to interpret microbial data and advise containment.
• Strong technical writing and cross-functional communication.

Responsibilities

• Provide technical support for microbial contamination events, EM excursions, personnel monitoring recoveries, and recurring organism patterns.
• Perform microbiological risk assessments related to aseptic processing, cleanroom operations, and contamination control gaps.
• Review microbial identification results and interpret organism source plausibility.
• Support investigations of contamination events, EM data, personnel monitoring, and facility conditions.
• Partner with QC Microbiology and related teams to identify adverse trends and escalation needs.
• Support APS/media fill assessments by evaluating contamination events and CAPA effectiveness.
• Assist development of escalation criteria for EM and contamination trends.
• Review deviations and CAPAs to provide microbiological rationale and risk input.
• Contribute to Sterility Assurance health summaries by assessing risk signals and CAPA effectiveness.
• Support development of site standards and technical guidance for microbial contamination control.

Skills

Microbiology

Environmental monitoring

Aseptic processing

Quality systems

CAPA

Education

Bachelor's degree in microbiology

Job description

Dexian is seeking a Sterility Assurance specialist to provide microbiology expertise for Berkeley's contamination control program. Focus areas include environmental monitoring, organism trends, and aseptic processing support, with an emphasis on data interpretation and CAPA effectiveness.

The role is an individual contributor, reporting to the Site Contamination Control/ Sterility Assurance Lead, with a 12–18 month contract and potential extension based on program needs.