Production Associate Dermagraft

This is an entry level position. The Associate will perform all activities involved in the aseptic processing of a living product (Dermagraft), under the direct supervision of the Dermagraft Team Leader/Dermagraft Supervisor/Manager. The Dermagraft Associate will support the Dermagraft Manufacturing department by performing the tasks that will assure the safe and timely processing of Dermagraft, working in both ISO 7 and ISO 8 cleanrooms. Responsible for aseptically manufacturing Dermagraft according to established Master Batch Records and Operating Procedures associated with cell-growth functions, including seeding cells, media changes, and harvesting of final product and packaging for commercial distribution. Responsible for the preparation of all media and sanitizing agents used in the Production areas as well as prepping materials for autoclaving and autoclaving the materials. Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, cGMP, and safety guidelines. Responsible for assuring batch records are complete and are compliant with all protocols. Responsible for proper operation of all clean room equipment. Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, cGMP’s, and safety.