Senior Aseptic Process Assurance Specialist

Harvestaff; Berkeley (CA); On-site; USD 101,000 - 117,000; Part time

Job summary

Harvestaff is seeking a Sterility Assurance Specialist in Berkeley, CA. This senior individual contributor role focuses on microbiology, aseptic processing, environmental and personnel monitoring, and CAPA effectiveness to support sterility assurance programs.

The candidate will review microbial identifications, investigate contamination events, and collaborate with QC Microbiology, Manufacturing, Quality Assurance, Engineering, and Validation teams.

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• Familiarity with EU GMP Annex 1, FDA aseptic processing guidance, USP microbiology chapters, PDA technical reports, and ICH Q9/Q10.

Responsibilities

• Provide technical support for microbial contamination events and environmental monitoring excursions.
• Perform microbiological risk assessments related to aseptic processing and cleanroom operations.
• Review microbial identification results and assess potential organism sources.
• Support investigations of Grade A/B/C/D contamination events.
• Review environmental monitoring data and facility conditions during investigations.
• Collaborate with QC Microbiology, QC Environmental Monitoring, and other teams to identify adverse trends.
• Support media fill assessments and CAPA effectiveness evaluations.
• Assist in developing risk-based escalation criteria for monitoring trends and contamination events.
• Review deviations and CAPAs with microbiological rationale and risk impact assessments.
• Contribute to Sterility Assurance health summaries and regulatory guidance development.
• Collaborate with QC Microbiology, Manufacturing, QA, Engineering, and Validation teams.
• Report to the Site Contamination Control/Sterility Assurance Lead.

Skills

QC Microbiology

Environmental Monitoring

Aseptic Processing

Contamination Control

Sterility Assurance

Biologics Manufacturing

CAPA & Root Cause

Technical Writing

Cross-functional Collaboration

Education

Bachelor’s degree in Microbiology/ Biology/ Biotechnology/ Pharmaceutical Sciences

EU GMP Annex 1 / FDA guidance familiarity

Job description

Harvestaff is seeking a Sterility Assurance Specialist in Berkeley, CA. This senior individual contributor role focuses on microbiology, aseptic processing, environmental and personnel monitoring, and CAPA effectiveness to support sterility assurance programs.

The candidate will review microbial identifications, investigate contamination events, and collaborate with QC Microbiology, Manufacturing, Quality Assurance, Engineering, and Validation teams.