Operator, PKG 1

Job Description

Job Description

Date

05 / 2018

Location

1300 Airport Road, North Brunswick NJ

Title

Operator, Packaging

Department

Packaging

Reports to

Supervisor, Packaging

FLSA (Exempt or Non-Exempt

Non-Exempt

Role Overview

The Packaging Operator is responsible for safely operating the packaging equipment to package in process products in accordance with company standard operating procedures and the packaging order.

The position includes set up, operation, cleaning, and preventative maintenance of all related equipment. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area.

Areas of Responsibility

• Follow batch records, SOP’s, and cGMP's guidelines to ensure product specifications and tolerances are met.
• Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc.

are fully completed, signed and in compliance with company standards and regulatory requirements.

• Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.
• Handle start up and shut down duties pertaining to equipment at the beginning and end of each shift.
• Load and unload items into packaging machine and remove rejected packages to be isolated as rejects or re-inspection.
• Execute packaging processes in accordance with packaging record / work orders.
• Troubleshoot and make appropriate adjustments to machine to maintain packaging specifications.
• Responsible for disposal of rejected tablets and packaging components in the designated area.
• Responsible to clear any jams that do not require a mechanic
• Dismantle and clean any accessories and equipment while also maintaining a clean work area.
• Fill in appropriate logbooks for equipment and rooms.
• Perform all material handling of products and components.
• Correctly document all steps on batch record.
• Maintain proper gowning and hygiene to ensure integrity of the product as per company policies.
• Works extended hours and occasional weekend overtime.
• Other duties as assigned

Other Responsibilities Including Safety :

N / A

Requirements

Education & Qualification :

• High school graduate or GED equivalent and / or 1+ years in bottle, blister, and other assorted tablet packaging
• Minimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries

Certifications, Licenses, Credentials :

N / A

Skills & Ability

• Demonstrates ability to work in a team and assist others.
• Able to follow written instructions precisely and perform basic math calculations as required.
• Understands and is knowledgeable of cGMP, OSHA standards etc.
• Mechanically inclined to understand inner workings of equipment.
• Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets.

Physical Requirements (lifting, etc.) :

• Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds.
• Must stand and walk on production floor a minimum of 8 hours per shift
• Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and / or above shoulder height, frequent bending from waist, or squatting, walking short distances.
• Occasionally works from a rolling ladder or step stool, must be able to lean over equipment as well as kneeling on the floor to clean under the equipment.
• Must be able wear all PPE including lab coat, face mask, booties, gloves, safety glasses / goggles and respirators.

Work Environment (Office, Warehouse, temperature extremes, etc.) :

Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes.

The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents.