GMP, USP

<71>, <61>, <62>, <85>, <797> , and FDA requirements. This role ensures sterility assurance and environmental control of aseptic manufacturing operations. Key ResponsibilitiesMicrobiological Testing Perform and/or oversee: Sterility testing (USP <71>) Bioburden testing (USP <61>/<62>) Bacterial endotoxin testing (USP <85>) Conduct method suitability testing Review and approve microbiology test results Environmental Monitoring (EM) Execute EM program for:

ISO 5, ISO 7

cleanrooms Viable air, surface, and personnel monitoring Trend EM data and identify adverse patterns Initiate investigations for excursions and OOS results Aseptic Process Support Support media fills (aseptic process simulations) Perform growth promotion testing Manage incubation of EM plates and media Oversee biological indicator testing (autoclaves, depyrogenation where applicable) Quality & Compliance Ensure compliance with: 21 CFR 211 (cGMP) USP microbiology chapters

Write/review:

SOPs Validation protocols/reports Deviations, CAPAs, and investigations Support FDA inspections, audits, and responses (483s) Data & Trending Perform trend analysis on: Environmental monitoring Sterility failures Bioburden levels Provide risk assessments and recommendations Qualifications Bachelor's degree in: Microbiology, Biology, or related field (required) 2-5+ years experience in: Sterile manufacturing (503B highly preferred) Strong knowledge of: USP <71>, <85>, <61>, <62> Aseptic technique and contamination control cGMP regulations (21 CFR 210/211) Core Competencies Strong analytical and investigation skills Deep understanding of aseptic processing risks High attention to detail and documentation accuracy Ability to operate in FDA inspection-ready environment Additional Expectations Must maintain training and gowning qualifications Must support weekend/holiday testing as needed Must uphold quality-first mindset over production pressure

Pay:

$25.00 - $30.00 per hour

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

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