What are the responsibilities and job description for the Operator, Coating position at US Pharma Lab?
Job Description
Date
05/2018
Location
1300 Airport Road, North Brunswick NJ
Title
Operator, Tablet Coating 1
Department
Standard Manufacturing
Reports to
Supervisor, Production
FLSA (Exempt or Non-Exempt
Non-Exempt
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.
Areas of Responsibility
Level 1
- Manufacture Production batches according to Batch Records, SOP’s, and cGMP 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.
- Check spray nozzles, piping, air pressure and boiler before start of the batch.
- Observes machines gauges and equipment calibration status and reports any deviations to production supervisor.
- Capable of running the following pieces of equipment/activity as well as train on new equipment, including troubleshooting equipment and accessories:
- Accela Coater – 48” & 60”
- Coating medium/solution preparation
- Assist in the revision and creation of department SOP’s.
- Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for: 1) coating issues such as sticking twinning, orange peel, film peel, blistering, surface edge erosion and over - wetting 2) general issues such as coating pan set up, performance, documentation, and material issues.
- Responsible for proper data entry in all batch record and logbook; and in process check control during coating process.
- Perform all related materials handling pertaining to the products being coated.
- Checks and verifies weight of tablets received from compression and reports deviations.
- Assist in the investigation of batch record 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.
- Knowledgeable in the relationship between spray rate, and inlet temperature, atomizing pressure, bed temperature, pan speed, and gun to bed distance.
- Meets all safety expectations and follows all safety practices.
- Works extended hours and occasional weekend overtime. Other duties as assigned
Level 2
- Manufacture Production batches according to Batch Records, SOP’s, and cGMP 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.
- Check spray nozzles, piping, air pressure and boiler before start of the batch.
- Observes machines gauges and equipment calibration status and reports any deviations to production supervisor.
- Capable of running the following pieces of equipment/activity as well as train on new equipment, including troubleshooting equipment and accessories:
- Accela Coater – 48” & 60”
- Coating medium/solution preparation
- Assist in the revision and creation of department SOP’s.
- Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for: 1) coating issues such as sticking twinning, orange peel, film peel, blistering, surface edge erosion and over - wetting 2) general issues such as coating pan set up, performance, documentation, and material issues.
- Responsible for proper data entry in all batch record and logbook; and in process check control during coating process.
- Perform all related materials handling pertaining to the products being coated.
- Checks and verifies weight of tablets received from compression and reports deviations.
- Assist in the investigation of batch record 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.
- Knowledgeable in the relationship between spray rate, and inlet temperature, atomizing pressure, bed temperature, pan speed, and gun to bed distance.
- Meets all safety expectations and follows all safety practices.
- Works extended hours and occasional weekend overtime.
- Other duties as assigned
Level 3
- Manufacture Production batches according to Batch Records, SOP’s, and cGMP 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.
- Check spray nozzles, piping, air pressure and boiler before start of the batch.
- Observes machines gauges and equipment calibration status and reports any deviations to production supervisor.
- Capable of running the following pieces of equipment/activity as well as train on new equipment, including troubleshooting equipment and accessories:
- Accela Coater – 48” & 60”
- Coating medium/solution preparation
- Assist in the revision and creation of department SOP’s.
- Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for: 1) coating issues such as sticking twinning, orange peel, film peel, blistering, surface edge erosion and over - wetting 2) general issues such as coating pan set up, performance, documentation, and material issues.
- Responsible for proper data entry in all batch record and logbook; and in process check control during coating process.
- Perform all related materials handling pertaining to the products being coated.
- Checks and verifies weight of tablets received from compression and reports deviations.
- Assist in the investigation of batch record 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.
- Knowledgeable in the relationship between spray rate, and inlet temperature, atomizing pressure, bed temperature, pan speed, and gun to bed distance.
- Meets all safety expectations and follows all safety practices.
- 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:
Level 1
- High school graduate or GED equivalent
- 6-12 months experience
- Operate 2 machines at one time & able to coat 10 different products.
Level 2
- High school graduate or GED equivalent
- 2-3 years of experience
- Operate 2 machines at one time & able to coat 20 different products.
- A clear understanding of the principal coating pan operation.
- Responsible for training
Level 3
- High school graduate or GED equivalent
- 4 years of experience
- Operate all machines.
- Solution prep, able to coat / troubleshoot the problems for all products.
- A thorough understanding of the causes and prevention of common coating problems.
- Responsible for training
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.
- Must have attention to detail.
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.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
