Direct Hire-Manager Aseptic Assurance

Kelly Scientific Resources is looking to fill a Direct placement position for an experienced Manager Aseptic Assurance in Marietta, PA. This client is known for highly competitive salaries and benefits, including health insurance plans, employee savings plans, etc. The Sterility Assurance Manager will be responsible for leading the development, implementation and maintenance of all aspects related to site wide sterility assurance. Responsibilities include but are not limited to the following:-Develops strategies and oversees the execution or site gowning processes, facility cleaning programs and execution of media simulations.-Develops and evaluates PQ validation studies to ensure compliance with sterility assurance.-Evaluates manufacturing operational practices and QC testing strategies to ensure compliance with regulatory requirements. -Evaluate new facility and equipment plans to ensure they meet aseptic regulations and requirements.Education and Experience' Bachelors degree in biology or microbiology, or equivalent technical discipline. ' 7+ years GMPMicrobiology laboratory role to include direct work with environmental monitoring of aseptic filling operations and sterility testing in a pharmaceutical setting ' Experience interfacing directly with the Food and Drug Administration inspectors.' Fully versed in GMP's, Guidelines, FDA, and other regulatory agency requirements for aseptic processing Kelly Scientific Resources is a highly specialized and rapidly expanding business unit of global staffing provider, Kelly Services, Inc. Kelly Scientific Resources leads the world in dedicated scientific and clinical research staffing, operating in 19 countries throughout North America, Europe, and the Pacific Rim. Since its launch in 1995, Kelly Scientific Resources has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. For more information, visit www.kellyscientific.com Learn more about company