cGMP Manufacturing Operator (ONSITE)(3rd Shift)

Qualifications:

• Training will occur on the first shift for 1-2 weeks.
• Must be able to work other shifts when required.
• Generally requires 2-4 years of related experience.

Required Competencies:

• Read and write English.
• Good communication skills.
• Ability to work as part of a team.
• Able to use a computer.
• Flexible to work OT to complete schedule.
• Organized, efficient, and detail-oriented.
• Ability to prioritize workload.
• Compliance to safety, cGMP, ISO14001, and ISO9001 regulations and ability to identify nonconformances.
• Ability to work under direct supervision.
• Must have the ability to understand and follow company procedures and specifications.
• Must be able to wear Personal Protective Equipment.

Desired Competency: Mechanically-inclined.

Responsibilities:

• Sets up, operates, and breaks down filling, labeling, and packaging equipment per SOPs.
• Monitors line performance and adjusts as necessary.
• Interprets instructions and specifications and uses them to set up equipment.
• Cleans and maintains equipment as needed.
• Notifies supervisor of maintenance and/or repairs needed on equipment.
• Prepares and completes accurate records/documentation related to quality and work in progress.
• Troubleshoots and corrects simple manufacturing problems in a timely manner.
• Maintains currency on all quality and safety requirements.
• Follow all cGMP' s, OSHA, and all company rules and regulations.
• Follow gowning/ aseptic techniques procedures.
• Monitor environmental conditions within the filling room (temperature, humidity, Blood agar plates, and particle counts).
• Monitor environmental conditions and storage of products.
• Precise, accurate, and completion of records and documentation related to filling, labeling, packaging, and inspection.
• Use the current documentation system to review and print specifications and Procedures.
• Use of PC for label generation and data tracking and evaluation.
• Provide training to entry-level operators.
• Maintain accurate component and inventory levels for production batches.
• Participate in Team communication and projects for Improvements.
• Maintains training binder audit-ready.