Responsibilities include: Identification and isolation of microorganisms (Biolog experience preferred), LAL (KTA and gel clot) endotoxin testing, maintain and preserve cultures, environmental monitoring of aseptic process areas for viable and non-viable contaminants, growth promotion, microbial limit testing, media preparation, bioburden and microbial enumeration testing, method suitability, sterility testing of finished products, sterilization procedures including autoclave operation, equipment standardization and validation techniques, working in pharmaceutical production and under aseptic conditions (ISO 5, Class 100), maintain laboratory notebooks and other required paperwork, maintain supplies and equipment. Able and willing to work in a fast paced team environment. Able to work weekends and overtime (a.m. and/or p.m.) as required. Skilled in planning, scheduling, and coordinating, time management, report writing, organizing, analytical ability, and leadership experience. Knowledge of FDA regulations, GMP, ISO, and USP is required.Experience & Education requirements: Bachelors Degree in Biology or Microbiology with at least 3-5 years in a microbiology lab setting. Candidates with extensive experience in lieu of a degree will be considered. Experience in a regulated industry, knowledge of cGMPs, GLPs, USP, change control, validation, OOS, CFR 210 and 211, and SOPs.Privately owned and operated since 1846, Hanford Pharmaceuticals is a highly respected contract manufacturer specializing in filling sterile, injectable antibiotics and non-sterile intra-mammary infusions. We offer a competitive salary and benefits package including 401(k). EOE
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