This position will work in the cGMP compliant QC Microbiology Laboratory supporting manufacture of biological products. Responsibilities include performing and providing support for functional aspects of the facility such as environmental monitoring (EM), microbiological testing (bioburden, bacterial endotoxin testing, growth promotion, biological indicators, stock cultures), water testing and validation support.
Work performed would support GMP manufacturing activities and release testing.
The incumbent will be expected to write and technically interpret controlled documents and reports, and review data and initiate investigations. Will interact with other departments to ensure that environmental monitoring scheduling and sample flow, are correctly maintained. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained. Will perform qualifications (equipment, media). Will create Test Record and SOPs. Will write validation reports.
Perform environmental monitoring of a biological production facility according to written procedures, while fully gowned, including operational monitoring and personnel monitoring during aseptic processing and filling.
• Oversee aliquoting/sterile filling operations and ensure acceptable aseptic techniques are employed on the floor.
• Qualify and perform microbiological testing such as bioburden, bacterial endotoxin and biological indicator testing.
• Draft SOPs, Test Records, Qualification Protocols, OOS Environmental Investigations and Summary reports and any supporting documents.
• Review data EM data, analyze and summarize data with guidance.
• Perform EM and utilities trending reports.
• Order laboratory supplies and maintain required inventory according to SOPs
• Perform Gram stains and arrange shipments of samples to contract labs for identification
• Maintains and ensures safe laboratory practices.
• Other assigned duties could include sample logging and assisting with shipment preparations
• LIMS experience preferred Experience
• A minimum of 5 years of work experience within the biological and/or pharmaceutical industry is preferred. A graduate degree and appropriate hands-on college coursework may substitute at an equivalent rate for required experience.
• Laboratory documentation, reports, and correspondence Hands on experience with aseptic technique, light microscopy, gram stain, bioburden testing, bacterial endotoxin testing and general microbiological techniques. Familiarity with microbial taxonomy and identification.
• Trending data.
• A Bachelor's degree in Life Sciences or Chemical/Biological Engineering.
WORK HOURS: Full-time/This position is a M-F 8am-5pm role.
Company DescriptionChipton Ross, a leader in staffing Technical Engineering, Information Technology (IT), Industrial, Professional, and Administrative career opportunities throughout the United States. (Now offering a Logistics Recruiting Division.)
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