Packaging Operator

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Packge Operator - 1st Shift

Schedule: Monday - Friday | 7:00 AM - 3:30 PM

Role Summary

The Packaging Operator operates and tends machines performing various functions, including filling, marking, labeling, tying, packing, or wrapping containers. You will execute assembly instructions per Batch Record requirements in compliance with cGMP guidelines
, ensuring all documentation is accurate, neat, and on time.

Key Accountabilities

Operations & Logistics

• Process Execution:
  Follow batch record instructions for manual processes in Primary and Secondary Packaging.
• Equipment Support:
  Assist in the operation and set-up of automated packaging equipment.
• Material Management:
  Assist in the reconciliation and movement (Chain of Custody) of materials between packaging areas and the warehouse.

Compliance & Documentation

• cGMP Standards:
  Provide support to Manufacturing, QA, Warehouse, and Facility operations by complying with company and FDA cGMP requirements.
• Reporting:
  Promptly report any observations to QA, Team Leads, or Managers regarding potential issues that could result in deviations or investigations.
• Continuous Learning:
  Complete training on SOPs to remain current on job requirements, logbook entries, and GMP documentation.

Facility Maintenance

• Sanitization:
  Perform cleaning and sanitization of Primary and Secondary Packaging rooms and equipment in accordance with department procedures.
• Validation Support:
  Assist Equipment Specialists in executing qualification protocols for new equipment as assigned.

Safety, Sustainability & Professionalism

• Safety First:
  Adhere to all defined Safety and Sustainability expectations. Stop work where deemed necessary to maintain safety.
• Communication:
  Attend all applicable meetings and discussions to support production schedules.
• Professionalism:
  Maintain a positive, professional, and confidential relationship with sponsors and colleagues.
• Regulatory Compliance:
  Comply with all state and federal regulatory requirements and guidelines.

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