Senior Quality Specialist (S192730 - E2656) - (Exton, PA)

Job DescriptionWe are seeking a Sr. Quality Specialist to join our team!OVERVIEWThe Sr. Quality Specialist - Technical Operations will have Quality Assurance functions within the Biologics Pilot Plant, to ensure adherence with cGMPs, EMEA, ICH and JP regulations. This individual will provide quality assurance support for equipment, systems, utilities, and sterilization processes throughout their respective lifecycles. This includes quality oversight for validation, automation, and facilities (maintenance / metrology) functional areas to support clinical and commercial production activities. The Sr. Quality Specialist will routinely interface with TrackWise for compliance record-related activities, as well as a Computerized Maintenance Management System for interactions with asset management records. Responsibilities Provide quality support for Validation documentation and processes within the Pilot Plant.