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.

06/25

1300 Airport Road, North Brunswick NJ

Operator, Tablet Coating 1

Standard Manufacturing

Supervisor, Production

Non-Exempt

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.

• 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
• Accela Coater – 48” & 60”
• Coating medium/solution preparation
• 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.
• 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

• 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…