Location: Portsmouth,NH, USA
12 HOUR SHIFTS - DAYS 7AM-7PM - ROTATING DAYS - ON SCHEDULE EVERY OTHER WEEKEND
The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials. Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate. Attain qualification for all assigned tasks and maintain individual training plan. Perform material movements, transfer raw materials, chemicals into, out of, across the production areas. Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Must be willing to gown and work in a clean room environment.
Administrative tasks attending shift exchange, meetings, sending/receiving emails, participating in projects. Perform other duties as assigned.