What are the responsibilities and job description for the Operator, Compression / Encapsulation position at US Pharma Lab?
Job Description
Role Overview
The Compression and Encapsulation Operator is responsible for the operation and set-up of tablet compression machines and set-up of automatic capsule filling machine in accordance with company standard operating procedures (SOPs) and cGMP regulations to ensure products meet applicable quality standards. This position includes set-up, operation, cleaning, and light mechanical adjustments. The Operator is accountable for overall production line performance including safety, quality, shrink, attainment, and line 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
- Makes necessary machine adjustments to ensure the smooth operation of the lines for required quality and quantity.
- 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.
- Assists supervisor in completion of deviation reports that outline both short- and long-term corrective action steps.
- Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for:
1) tableting issues such as sticking and picking, capping, chipping, compressibility, delamination, disintegration, and black spots on surface
2) general issues such as machine set-up, machine performance, and documentation. - Performs calculations and physical updates to improve product performance and
completes documentation related to changes, ingredient change forms, in-process deviations, batch record corrections, processing forms, etc.
- Performs basic and routine maintenance activities.
- Cross-trains in other areas to be able to support the manufacturing process as needed.
- Disassembles, cleans/ sanitizes, and reassembles all required equipment.
- Meets all safety expectations and follows all safety practices.
- Maintains proper gowning and hygiene to ensure integrity of the product as per cGMP’s and company policies.
- Must be able to work extended work hours and weekend overtime.
- Performs all other duties as assigned by immediate supervisor
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
- 3 years Compression & Encapsulation experience
- Minimum of one (1) year work experience in nutritional 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 to detail and accuracy with numbers.
- 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 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.):
