Senior QC Microbiologist/ Manager QC Microbiology

ZYLIDAC BIO LLC

Emeryville, CA

Job Description

Description:

Perform and review microbiological testing, including bioburden, endotoxin (LAL), sterility testing, and microbial identification
Oversee and trend environmental monitoring (EM) data in classified cleanroom areas (ISO 5–8 / Grade A–D) and utilities (WFI, Compressed gases)
Oversee Process monitoring and Media fills
Lead investigations for OOS, OOT, EM excursions, and contamination events
Author and review deviations, CAPAs, SOPs, and technical reports
Support method validation, verification, and transfer activities
Support cleaning validation/verification and disinfectant efficacy studies
Ensure compliance with GMP, USP, and regulatory requirements (FDA, EMA, ICH)
Act as SME for microbiology during audits and inspections
Train and mentor junior staff and support cross-functional teams
Contribute to contamination control strategy (CCS) and continuous improvement initiatives

Requirements:

Bachelor’s or Master’s degree in Microbiology, Biology, or related field
10+ years of QC microbiology experience in a biologics, pharmaceutical, or aseptic manufacturing environment

Strong knowledge of:

GMP regulations (FDA 21 CFR Parts 210/211, EU GMP Annex 1)
USP microbiology chapters (e.g., [61], [62], [71], [85], [1116])
Environmental monitoring in cleanrooms

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Vacancy posted 6 days ago

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