Job Description

Job Responsibilities:

• Follow batch record instructions in the execution of manual process for Primary and Secondary Packaging as applicable.
• Assist in the operation and set-up of automated equipment in the performance of certain primary or secondary packaging operations.
• Assist in the reconciliation and movement (Chain of custody) of materials between packaging areas and the warehouse.
• Report any observations to QA, Team Lead, Equipment Specialist CPS Project Coordinator or Manager of potential issues that could result in deviation or investigation.
• Perform Cleaning and Sanitization of Primary and Secondary Packaging rooms.
• Support the Equipment Specialist in the execution of qualification protocols for new equipment as assigned.
• Training on SOPs to remain current for job requirements, logbook entries and GMP documentation.
• Attend applicable meetings, discussions, etc., in support of these projects to meet the Production Schedule.
• Participate in safety processes and meetings as applicable.
• Maintain a positive, professional and confidential relationship with sponsors. Comply with all state and federal regulatory requirements and guidelines.
• Other applicable duties as assigned.
• Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
• Stop work where deemed necessary to maintain safety  

Skills:

• Packaging
• Labeling
• GMP  

Education/Experience:

• Operates and tends machine that performs one or more packaging functions, such as filling, marking, labeling, tying, packing, or wrapping containers. 1-3 Years Experience Summary

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