Job Location : Hicksville,NY, USA
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.