Senior Sterility Assurance & Microbiology Specialist

Dexian

Albany (CA)

On-site

USD 69,000 - 72,000

Full time

3 days ago

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Job summary

Dexian seeks a Quality Specialist / Sterility Assurance Specialist (Microbiology) for a 12-18 month contract at the Berkeley site in California. The role provides senior microbiology and aseptic processing expertise to support environmental monitoring, personnel monitoring, organism trends, and contamination control within the Sterility Assurance program.

You will review microbial data, support risk assessments, and CAPA effectiveness, and collaborate with QC Microbiology, EMO, QA, and

Qualifications

Bachelor's degree in microbiology or related field.
5+ years in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, contamination control, or biologics/cell therapy manufacturing.
Strong written and cross-functional communication skills.

Responsibilities

Provide technical support for microbial contamination events and EM excursions.
Perform microbiological risk assessments related to aseptic processing and cleanroom operations.
Review microbial identifications and organism sources.
Support investigation of contamination events and CAPA effectiveness.
Collaborate with QC Microbiology, QC EMO, QA and Manufacturing to identify trends.
Assist with APS/media fill assessments and CAPA reviews.
Contribute to Sterility Assurance health summaries and guidance development.