Operator, Coating

Role Overview

The Tablet Coating Operator is responsible for the operation and set-up of compression machines 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 Coating Operator is accountable for overall process performance including safety, quality, shrink, attainment, and 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.

Responsibilities

• Manufacture production batches according to Batch Records, SOP's, and cGMP guidelines to ensure product specifications and tolerances are met.
• Ensure full compliance with Company policies, procedures, GMP's, Ethical Business Practice, and SOP's at all times.
• Ensure documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.
• Ensure that product meets applicable quality standards, including inspection for quality during operation and performing all required sampling and testing.
• Check spray nozzles, piping, air pressure and boiler before start of the batch.
• Observe machines gauges and equipment calibration status and report any deviations to production supervisor.
• Operate Accela Coater – 48" & 60" and perform coating medium/solution preparation.
• Perform all related materials handling pertaining to the products being coated.
• Check and verify weight of tablets received from compression and report deviations.
• Correctly document all steps on batch record.
• Adhere to all company policies.
• Maintain proper gowning and hygiene to ensure integrity of the product as per cGMP's and company policies.
• Perform cleaning of equipment and processing room and dispose of rejected tablet and powder as per compliance requirements.
• Maintain knowledge of the relationship between spray rate, inlet temperature, atomizing pressure, bed temperature, pan speed, and gun to bed distance.
• Meet all safety expectations and follow all safety practices.
• Work extended hours and occasional weekend overtime.
• Perform other duties as assigned.

Qualifications by Level

Level 1
High school graduate or GED equivalent with 1-2 years of experience.

Level 2
High school graduate or GED equivalent with 2-4 years of experience. Must be able to operate 2 machines at one time and have a clear understanding of the principal coating pan operation. Responsible for training.

Level 3
High school graduate or GED equivalent with 5+ years of experience. Must be able to operate all machines, perform solution prep, coat and troubleshoot problems for all products, and have a thorough understanding of the causes and prevention of common coating problems. Responsible for training and able to work with minimum to no supervision.

Additional Responsibilities by Level

Level 2

• Utilize problem-solving skills to investigate and troubleshoot product issues and recommend solutions for coating issues (sticking, twinning, orange peel, film peel, blistering, surface edge erosion, over-wetting) and general issues (coating pan set up, performance, documentation, material issues).
• Assist in the investigation of batch record deviations.

Level 3

• Assist in the revision and creation of department SOP's.
• Utilize problem-solving skills to investigate and troubleshoot product issues and recommend solutions for coating issues (sticking, twinning, orange peel, film peel, blistering, surface edge erosion, over-wetting) and general issues (coating pan set up, performance, documentation, material issues).
• Assist in the investigation of batch record deviations.

Skills & Abilities

• 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.
• Must have attention to detail.

Physical Requirements

• 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 able to lean over equipment as well as kneel 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

Work is regularly performed inside a manufacturing environment where temperatures can be moderate, with exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.

Pay

• Level 1: $21.00 - $25.00 per hour
• Level 2: $23.00 - $28.00 per hour
• Level 3: $28.00 - $38.00 per hour

Schedule

3rd shift - 11:00 PM to 7:00 AM. Extended hours and occasional weekend overtime required.

Benefits

• Medical, dental, and vision insurance
• Short and long term disability
• Basic life insurance, supplemental life insurance, and AD&D insurance
• Matched 401(k) savings plan
• Premium pay opportunities including overtime, shift differential, holiday pay, and sick time
• Up to 10 days of vacation the first year, growing to 12 days starting the second year of employment