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.