Job Purpose
Responsible for releasing and controlling production lines, ensuring production line staff are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring all batches.
Major Accountabilities
• Provides direction/line assignments to packaging personnel.
• Starts up production lines at the beginning of the shift and at the start of batches to release lines.
• Monitors lines including correct weights, lot number, expiration date and scans in drums of product.
• Calculates and documents in Filling Instructions tare weights for each packaging component number.
• Reviews batch paperwork for accuracy and issues to the batch records clerk.
• Checks and prepares paperwork for upcoming batches.
• Sets up and monitors cleaning and filling Validation batches according to protocols.
• Accepts and controls labels for individual orders. Counts and verifies labeling, packaging components and finished product against pick list, material list report, and palletizing pattern.
• Processes paperwork for Labeling Returns and brings returns to the Label Room or the Batch Clerks Office.
• Verifies correctness of components and product per the Filling Instructions.
• Prints pallet tickets and quarantine tags on finished product skids.
• Enters counts electronically or in pallet book and documents line status in logbooks.
• Performs line clearances, counts and documents returns to stock.
• Performs SAP transactions such as Return to Stock (RTS) or paper transfer using scanning guns.
• Sets up electronic marquees indicating the product information for production lines.
• May calibrate scales/checkweighers daily or when moved to new locations on the production floor.
• Checks all cleaned parts on the production line.
• Responsible for Daily Packaging Thruput/Changeover, and Labor tracking reports.
• Provides feedback on operator performance.
• Interacts with production management, mechanics, and Quality Assurance.
• Participates in training of new employees.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
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