Aseptic Sterility Assurance Lead, Microbiology (Berkeley)

KellyMitchell Group; Berkeley (CA); Hybrid; USD 48,000 - 69,000; Full time

Benefits offered by this job

Medical, Dental, & Vision Insurance

Employee-Owned Profit Sharing (ESOP)

401K offered

Job summary

KellyMitchell Group is seeking a Sterility Assurance Specialist for a leading Healthcare & Life Sciences provider in Berkeley, CA. The role is onsite with hybrid flexibility and 9am PST start.

The candidate should have a Bachelor’s in a related science and 5+ years in QC Microbiology, environmental monitoring, aseptic processing, or contamination control, with strong data interpretation and documentation skills.

Qualifications

• Bachelor’s degree in microbiology, biology, biotechnology, pharmaceutical sciences, or related field.
• 5+ years of experience in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, or contamination control.
• Strong understanding of environmental/personal monitoring, bioburden, aseptic technique, and contamination investigations.
• Experience supporting GMP deviations, CAPAs, root cause analysis, risk assessments, and technical documentation.

Responsibilities

• Provide microbiology and aseptic processing expertise to support Site Sterility Assurance and Contamination Control.
• Focus on environmental monitoring reports, personnel monitoring, organism trends, and contamination investigations.
• Help ensure microbial data and contamination events are interpreted within an integrated sterility strategy.

Skills

Sterility assurance

Environmental monitoring

Aseptic processing

Root cause analysis

Data interpretation

Education

Bachelor’s degree in microbiology or related scientific discipline

Job description

KellyMitchell Group is seeking a Sterility Assurance Specialist for a leading Healthcare & Life Sciences provider in Berkeley, CA. The role is onsite with hybrid flexibility and 9am PST start.

The candidate should have a Bachelor’s in a related science and 5+ years in QC Microbiology, environmental monitoring, aseptic processing, or contamination control, with strong data interpretation and documentation skills.