1st Shift Packaging Machine Operator

Job Description

Job Description

Summary

The Machine Operator has the primary responsibility of setting up Packaging Equipment, and assisting with Packaging operations within their assigned production rooms.

General Duties and Responsibilities:

1. Adheres to proper cGMP’s including good housekeeping, proper protection of product quality and integrity, and personal hygiene.
2. Reads and understands written instructions and SOPs.
3. Completes accurate and timely documentation to comply with FDA regulations.
4. Set up, and assist with monitoring Packaging equipment, including certain types of pill counters, cappers, sealers, and labelers used in certain production lines.
5. Adheres to all regulatory guidelines including execution of supporting product documentation.
6. Adheres to all safety practices.
7. Completes required Safety Orientation by understanding basic concepts of the procedures.
8. Operates some packaging machines, meeting quality and production goals
9. Records and reports any damage of machinery or equipment to Packaging Lead or Supervisor.
10. Restock items in the gowning room as necessary
11. Monitors machines as required to ensure finished products meet quality standards.
12. Assist with equipment changeovers
13. Communicates with MOII or MOIII if equipment issues are identified
14. Refill totes with product as required
15. Place the required cotton, desiccant or both into a container and ensure each container has the required components.
16. Manage rejected packaged items.
17. Removes finished items from machine and separate rejected items.
18. Inspects and removes defective products and packaging material.
19. Load finished good containers onto carts as necessary
20. Starts machine by engaging controls.
21. Perform in-process inspections
22. Supplies materials to conveyors, hoppers, or other feeding devices.
23. Assist with cleaning production room and equipment as assigned
24. Performs other packaging-related duties as assigned.

Supervision:

Received: Supervised by the Senior Packaging Lead.

Given:

Equipment:

1. In-Feed Turntable, Pill Counter, Bottle Capper, Bottle Labeler, Out-Feed Turntable, Cap Sealer, forklifts, dollies, pallet jack, pushcart, Job Costing system, sterilization and pedigree system (RFID), standard office equipment, and computers.

Physical/Cognitive Requirements:

1. Must be able to exert up to 50 lbs. of force frequently, and/or up to 20 lbs. of force constantly to move objects.
2. Must operate equipment to assist moving inventory including pushcart, hand truck, forklift and pallet jack approximately 10% of each day.
3. Must lift, bend, twist, stoop, climb, and pull in the process of moving boxes and packages from one location to another.
4. Must be comfortable wearing a wear full-face respirator while performing job responsibilities.
5. Must climb stairs in order to store items in storage racks.
6. Must be able to package between 25 and 40 bottles a minute.
7. May be required to work longer than the typical 8-hour workday.

Miscellaneous Requirements:

1. Maintain a strong attendance record.
2. Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.
3. Mastered Operation of equipment for the assigned room

Attitude:

1. Individual must be enthusiastic, concerned with job and company as whole
2. Desire and ability to maintain openness with supervisor and management.
3. Self-disciplined with a desire to achieve results.
4. Punctual, flexible and detail oriented.