Gown Qualified Operator

Summary:

These openings are for 3rd Shift: 11pm-7am Monday- Friday

The Gown Qualified Operator is responsible for the use of filling equipment in a controlled or non-controlled area to fill and seal product into containers as specified by batch record, and in accordance with all operational SOPs and cGMP requirements.This may include but is not limited to: set-up of room and equipment for production, operate equipment to meet product specifications and batch record requirements, ensures correct components and product according to production schedule and batch record, and equipment and room cleaning and sanitization.

Other responsibilites will include:

• Routine gowning
• Component and material transfer.
• Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP).
• Operate equipment within assigned controlled non-classified and controlled classified areas.
• The use of aseptic techniques in a clean room environment.

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