Qc Microbiology, Analyst I

Perform Quality Control Microbiological testing of Environmental Monitoring (EM) - for viable air, non-viable particulates, surface viable monitoring in manufacturing areas/cleanrooms. Perform testing for gram staining/microbial identification, Media growth promotion, endotoxin testing, plate reading, and documentation. Support cleanroom qualification, gowning qualification, aseptic process qualification and personnel monitoring for manufacturing activities. Receive samples for analysis, ship samples for contract lab testing, enter/review data, and organize data according to cGDP/GMP requirements. Revise SOPs/forms, and Initiate incident reports for OOS results -support root cause analysis for EM excursions. Assist in EM data review for trending and other technical documentation or projects. Perform lab set up, housekeeping/routine cleaning, schedule equipment for preventative maintenance, and organization of laboratory areas in accordance with cGLP/GMP. Required:
Bachelor's degree in biology, microbiology or related life science with 1-2 years' relevant GMP/pharma/microbiology laboratory experience Ability/Flexibility to work evenings and weekends/holidays is required- to support manufacturing operations Good knowledge of Aseptic technique and common microbiological testing Knowledge of relevant, compliance and guidance documents, documentation (ALCOA +) and data organization Must be able to gown into cleanrooms in support of testing and manufacturing activities Detail oriented, willingness to learn and follow instructions Interpersonal skills and ability to contribute to the success of a team