Microbiologist Specialist - MSAT *PC 1603

Job description

Your Role: This position will be in the Manufacturing Science and Technology team (MS&T) at Gaithersburg, MD site. This position is responsible for life cycle management of microbiological methods, worksheets and leading microbiological method related quality events (change controls, deviations, CAPAs). In addition, this position will support MSAT team to manage microbiological method changes, qualification of materials, supplier change notifications related to the microbiological testing methods. Additionally, the specialist will partner closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively. Essential Duties and Responsibilities: Others: Requirements: Skills: - Investigate Deviations: Analyze and investigate deviations or out-of-specification (OOS) results from Environmental Monitoring (EM) and Microbiological testing to identify their true root cause. - Change Management: Initiate/owns change controls or respective quality event to drive changes to the method, equipment, or material. - Documentation: Maintain accurate, detailed, and objective docume...