Packaging Operator

The ideal candidate will have strong experience in clinical pharmaceutical packaging, cGMP operations, PQS, labeling, documentation, and automated systems and a proven ability to execute final packaging activities safely and efficiently while meeting production schedules and quality standards.

Responsibilities:

• Attend required cGMP, safety, and on-the-job training and maintain qualifications.
• Maintain a safe and clean work environment and support continuous improvements in quality, safety, and efficiency.
• Adopt a teamwork approach to meet production needs and schedules within the department.
• Act as a Super User or Subject Matter Expert in labeling and packaging activities as assigned.
• Complete process documentation per cGMP, including FNs, batch records, and room/equipment logs.
• Execute printing, labeling, and final packaging using appropriate automated systems with a focus on quality and efficiency.
• Perform receiving and delivery of products and materials using approved procedures and systems.
• Review batch records, forms, and documents in a timely manner.
• Safely set up, operate, and troubleshoot equipment and GMP systems.
• Manage process-related issues with cross-functional groups and initiate discrepancies when required.
• Pick up and deliver samples as assigned.
• Conduct visual and dimensional inspections of labeling and packaging components, including labels, inserts, folding cartons, and container closures.
• Perform documentation review of COA-released components.
• Support training initiatives in collaboration with PTD Training.
• Contribute to department projects, including investigations, analysis, solution formulation, process documentation, and communication of results.
• Support Change Management activities and complete assigned project work.

Required Skills & Qualifications:

• Proficiency with cGMP documentation, batch records, and electronic or automated packaging systems.
• Skilled in equipment setup, operation, and basic troubleshooting in a controlled environment.
• Strong attention to detail for visual and dimensional inspections and documentation review.
• Experience level: High School diploma with 3–6 years related production experience, or BS/BA with 1 year technical experience.

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