Job Description: 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 prod ucts and materials.
Roles & Responsibilities: - Set up operate equipment and monitor production processes including cleaninplace (CIP) and steaminplace (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.
- Food service.
- Cooks (can follow recipes).
- Pharmacy techs.
- Mechanical aptitude.
- Robotics.
- Computer skills (this is ever more important as our suites are more and more automated).
- EMTs.
- Tech Support.
- Anything in which they need to follow SOPs Guidelines industry regulations.
- Sig Sauer employees.
- Security guards.
- Nurses/nurses aids.