Manufacturing Associate

Summary

• The Manufacturing Associate I is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply.
• The Manufacturing Associate I is expected to fully participate in both departmental projects and any quality working teams that may be applicable.
• This position shall be responsible for the hands on execution of activities as they relate to the manufacturing of products.

Essential Duties & Responsibilities

• Clean, Set up, operate, and teardown of equipment in the department such as tanks, filtration systems, room sanitization, etc.
• Complete relevant paperwork following GDP/GMP guidelines.
• Will be responsible for training on the manufacturing process. Manually clean portable equipment and small parts.
• Work with other departments to ensure adherance to production schedule.
• Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).
• Monitor and record critical process parameters. Write, revise and review pertinent documentation as appropriate.
• Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.
• Prepare media and buffers solutions.
• Perform sampling using aseptic techniques.
• Receive and distribute supplies into production area as necessary.
• Execute Minor Document Change Control. Issue Documents. Generate Work Orders.
• Assist with process/equipment validation and data analysis. Understanding of supplier/customer process streams and interdependencies.
• Troubleshoot and identify atypical conditions and how to respond to them.
• May train others on complex processes and explain process to others.
• Participate on Continuous Improvement Teams.
  
  Education and/or Experience Requires
• Bachelors degree or AA degree with 2 years of related work experience or a high school diploma with a minimum of 4 years of related work experience. Scientific degree preferred.
• Recommended experience: 0-3 years for Associate level, 4-7 years Intermediate level, and 8+ for Senior level hires.