Packaging Operator - Shift 3

About the role

The Packaging Operator works within the Finishing/Packaging Complex. They inspect, label, and package pharmaceutical products to meet client demand and expectations. They contribute to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Responsibilities

• Label, package, and document per written instructions
• Pack product in boxes, cartons, syringes, vials, blisters
• Count materials/product to ensure accurate count
• Apply labels to various components
• Replenish packaging materials to areas/work cells as directed by Group Leader
• Monitor and document TOR (time out of refrigeration)
• Complete batch record protocol steps at the time of performance
• Inspect, verify and track
• Scan printed materials
• Manually examine printed materials and products to ensure specifications are met, including variable text printed on-line
• Verify incoming materials for use
• Inspect product/materials for defects
• Perform bar code and systems challenges (as applicable) for equipment used
• Complete end of batch reconciliation and count verification
• Retrieve product samples
• Monitor and ensure appropriate downtime and efficiency information is logged accurately
• Set-up, tear down and clear
• Participate and assist with line clearance activities
• Remove batch related materials from production area
• Ensure electronic inventory transactions for inventory tracking movement and material verification are completed
• Clean and clear debris from all work areas
• Dispose of rejects in the appropriate disposal area following reconciliation
• Stage materials in the appropriate designated locations
• Enter and verify information in logbooks, as needed
• Apply representation samples to the batch records as required
• Indicate appropriate signals with HMI (human machine interface) to track clearance, set-up, time, etc.

Requirements

• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of standard operating procedures, specifications, and job-specific training materials
• Requires the operations of multiple types of equipment related to the packaging operations as well as hand operated equipment including, but not limited to, such things as barcode scanners, scales and tape gun

Physical /safety requirements

• Occasional (0-33%): Walking, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling
• Frequent (34-66%): Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls
• Constant (67-100%): Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Desirable qualifications

• High School diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred
• Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals

Work environment

A controlled pharmaceutical environment including wearing long sleeves, safety toe shoes, gloves and safety glasses. Ability to work in a team environment on a variety of automated and semi-automated packaging lines.