US_Packaging Operator II_CO

Packaging Operator II (Contract) - Clinical Packaging & Pharmaceutical Manufacturing Join a High-Quality Pharmaceutical Packaging Team

• Packaging & Production Operations Execute printing, labeling, and final packaging activities according to established procedures and quality standards. Receive, process, and deliver products and materials using automated systems. Safely set up, operate, monitor, and troubleshoot packaging equipment and GMP systems. Perform sample pickup and delivery activities as assigned. Support production schedules while maintaining accuracy, efficiency, and compliance.
• Quality & Compliance Complete and maintain required documentation, including batch records, forms, facility notifications, and equipment usage logs. Review batch records, forms, and supporting documentation in a timely manner. Conduct visual and dimensional inspections of packaging components, including labels, inserts, folding cartons, and container closure components. Perform documentation reviews for released components and materials. Identify process issues, collaborate with cross-functional teams, and initiate discrepancies when necessary.
  
  Ensure all activities comply with cGMP, quality, and safety standards.
• Continuous Improvement & Team Support Participate in quality, safety, and process improvement initiatives. Support departmental projects, investigations, process documentation, and solution development. Assist with change management activities and project-based assignments. Support departmental training programs and collaborate with training teams. Serve as a Subject Matter Expert (SME) or Super User for labeling and packaging operations when applicable. Foster a collaborative team environment that supports operational excellence.

Education & Experience One of the following is required:
High School Diploma or equivalent with 3-6 years of related production or manufacturing experience, preferably in a regulated environment; OR Bachelor's degree (BS/BA) with 1+ year of technical or manufacturing experience.

Desired Skills Strong understanding of pharmaceutical manufacturing, packaging, labeling, and GMP operations. Ability to work independently while following established procedures and quality requirements. Experience resolving moderately complex production and process issues. Strong attention to detail, documentation accuracy, and regulatory compliance. Effective communication and collaboration skills. Ability to provide recommendations for operational improvements and process enhancements.

Work within controlled manufacturing environments requiring adherence to gowning procedures and safety protocols. Personal protective equipment (PPE) may include gloves, safety glasses, and steel-toe footwear. Ability to operate computers, RF devices, and automated manufacturing systems. Flexibility to work overtime and adjust schedules as business needs require. Ability to stand or sit for extended periods. Ability to perform repetitive packaging and visual inspection tasks for prolonged durations.

Must be able to lift up to 40 pounds and push/pull loads requiring more than 75 pounds of force.

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