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Operator, Beads MFG 2
4 months ago
Date
11/2020
Location
1300 Airport Road, North Brunswick NJ
Title
Production Operator- Beads Division (Associate, Operator 1, Operator 2, Operator 3, Lead)
Department
Standard Manufacturing - Beads
Reports to
Production Supervisor
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The Beads Operator is responsible for the operation and set up of mills, granulators, drying oven, blenders, screening equipment, fluid bed dryers, feeders, etc. in accordance with company standard operating procedures. The position includes set up, operation, cleaning, and preventative maintenance of all related equipment. The Operator is accountable for overall performance including safety, quality, shrink, attainment, and production efficiency. 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.
- Complete all labeling and inventory movements to ensure accurate inventory control.
- Dismantle and clean any accessories and equipment while also maintaining a clean work area.
- Train in the operation, cleaning and set-up of the following pieces of equipment as well as new equipment:
- Vector Fluid Bed Dryer, inserts, and ancillary equipment
- K-Tron powder feeder
- Air Classifying Mill
- Fitz mill/Multi mill
- Double cone/V- blenders: 6cu. ft. to 150 cu. ft.
- Screening/ sieving equipment
- Fill in appropriate logbooks for equipment and rooms.
- Perform all material handling of products and components.
- Correctly document all steps on batch record.
- Participate in any investigation for a deviation involving a 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:
- Works in a safe and responsible manner to create an injury-free and incident-free workplace.
- Complies with all job-related safety and other training requirements.
- Keeps management informed of area activities and of any significant problems.
Requirements
Education & Qualification:
- High school graduate or GED equivalent
- >2 years’ experience plus responsibilities above
- Operates, cleans, sets all machines in work area.
- A clear understanding of the principal functions of the bead department.
- Completes batch card independently, follow SOP’s and GMP’s strictly
- Certified forklift operator.
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 the inner workings of the equipment.
- Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets.
Physical Requirements (lifting, etc.):
- Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.
- Must stand and walk on the production floor for a minimum of 6 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 the waist, or squatting, walking short distances.
- Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.
- Must be able to wear all PPE including a 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. Employees can be exposed daily to chemicals and cleaning agents.
