Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. Performs validation, technology transfer, and troubleshooting. Writes policy procedures for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.