Summary of Primary Responsibilities:
The Manufacturing Operator is responsible for performing manufacturing operations for the production of commercial medical device and drug products according to cGMP regulations.
- Perform Manufacturing procedures inside class 10,000-100 clean room in accordance to established SOPs, cGMPs, and safety regulations.
- Complete the set-up, operation, disassembly, and cleaning of process equipment according to standard operating procedures.
- Complete the preparation and execution of equipment and materials for autoclaving.
- Operate laboratory instruments such as balances, pH meters, conductivity meters, mixers, autoclaves, etc.
- Execute and witness batch record instructions during cGMP operations.
- Document production activities according to GDPs in corresponding batch records and log sheets.
- Initiates Quality exception paperwork involving root cause investigations.
Works on assignments that are routine or semi-routine in nature where ability to recognize deviation from accepted practice is required. Normally receives general instructions on routine work, detailed instructions on new assignments.
Experience, Knowledge, and Skills Required:
- Requires a high school diploma.
- 2+ years related experience in a manufacturing environment
- Knowledge of GMP documentation and regulations
- Basic computer skills including the ability to input data, prior experience with computerized control panels preferred
- Ability to communicate verbally and read, comprehend and prepare documents in English
- Able to lift and move equipment into place with and without assistance