• Multiple years experience in Quality Assurance for the pharmaceutical and medical device industry. •Responsible for organizing and assigning QS Microbiology Laboratory personnel QA testing of manufactured product including bioburden of pre-sterilized product, sterility and BET (kinetic turbidimetric) testing of sterilized/finished product, environmental monitoring of manufacturing and laboratory clean rooms including surface, viable and non-viable air quality, water, and compressed air sampling •Write NDA, and ANDA submissions for new drug products •Write PAS and CBE-30 for changes to current drug products •Write, review and/or approve test protocols and reports, microbiological method and test equipment validation protocols and reports, and other controlled documentation and reports in accordance with 21 CFR Part 11, 210, 211, 820, ISO 13485, and current USP and AAMI guidelines •Manage internal audits (in house and corporate), external regulatory audits (FDA and ISO), and vendor audits as they pertain to microbiological quality •Responsible for presenting quality metrics to executive management •Provide technical guidance and support to manufacturing engineers, quality engineers, R&D, functional groups, and management •Responsible for management of all laboratory projects including facilities, equipment, and new method development. Capital procurement, budgeting, timeline management and progress reporting to upper management