2nd Shift Packaging Operator
Summary:
Leads and performs a variety of process duties according to batch record and Standard Operating Procedures (SOP’s) on a pharmaceutical packaging line, but not limited to, operating machines, and manual packing of bottles/blister packs into boxes.
Essential Job Functions:
- Carries out responsibilities in accordance with the organization policies, procedures, and state, federal and local laws.
- Works on automated machinery operating bottle and blister packaging equipment.
- Ensures batch records, equipment logbooks, and other relevant records are completed correctly and are current.
- Adheres to company uniform and gowning policies.
- Reports process or equipment problems to area supervision.
- Performs changeovers and set-up of equipment for processing operations.
- Possesses mechanical aptitude and/or ability for basic equipment troubleshooting.
- Cleans and maintains packaging rooms and equipment.
- Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
- Follows established department SOP’s and batch record instructions.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations.
- Appropriately utilizes Personal Protective Equipment (PPE) at all times.
- Other job duties as assigned.
Knowledge of:
- Current Good Manufacturing Practices (cGMP’s).
- Food and Drug Administration (FDA), and other regulatory requirements.
- SOP’s, equipment, and safety practices.
- Packaging processes and equipment procedures.
- Business English usage and spelling.
- Basic Math Computations.
Skilled in:
- Follows verbal and written directions.
- Communicates clearly and concisely, both orally and in writing.
- Basic computer knowledge.
- Making corrections and writing comments in the batch record.
- Establish and maintain cooperative working relationships with others.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations.
Physical Requirements:
- Employees in this position are subject to extended periods of standing, walking, pushing, pulling, bending, vision monitoring, lifting equipment or materials up to 50 pounds.
Preferred Qualifications:
- High School Diploma or equivalent
- 2-5 years of experience in pharmaceutical, medical device, food manufacturing/packaging environment.