Machine Operator Jobs

The incumbent will assure individual compliance with the FDA regulations, CGMPs and all other applicable international regulatory compliance requirements, applicable department programs, including training, documentation, standard operating procedures, policies and procedures.
Key Activities/ Responsibilities

• Communicate problems and concerns with equipment and personnel to Management.
• Direct Packaging line crew activities (monitor set-up, packaging, clean-up.) 6. Able to log in and execute through OEE System.
• Know all procedures and perform paperwork documentation for all packaging operations (unit dose, bottle liquid products), including Schedule Il materials.
• Able to setup, operate, teardown, and clean the following efficiently and effectively, following all safety procedures.
• Perform all other duties as assigned by Packaging Supervisor/Management.
• Monitor the quality of the container being packaged and take corrective actions to maintain the quality of the product.
• Thermoform packaging machines b. Liquid Bottle Filler and Equipment
• Ensure that all current Good Manufacturing Practices (cGMPs) and SOPs are adhered to as related to the equipment, work area, and personnel.
• Table top filler (FD-Pharma)
• Interact with on-line QA to assure all filling / packaging specifications are being met.
• Perform PMs for packaging equipment.
• Serialization Equipment (Antares)
• Maintain an orderly and clean area.
• Attend training sessions to increase knowledge in machine operation, safety, cGMPs, and procedures.
• Document pertinent information onto appropriate Batch Records neatly and accurately. Know the function and purpose of batch record paperwork.

Requirements

• Must be able to read and write English fluently and neatly.
• An equivalent combination of education, training, and experience may substitute.
• Able to lift 60 pounds effectively and stand for long periods of time.
• One year machine operator experience.
• A high school diploma or equivalent and a demonstrated mechanical aptitude is required.