Operator, Compression​/Encapsulation

Operator, Compression & Encapsulation

Location:

1300 Airport Road, North Brunswick NJ

Department:
Standard Manufacturing

Reports To:

Production Supervisor

Role Overview

The Compression and Encapsulation Operator is responsible for the operation and set-up of tablet compression machines and 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

Level 1:

• 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.
• Utilizes problem-solving skills to identify and report to the team lead or supervisor troubleshoot product issues.
• 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.

Level 2:

• 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.
• Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for:
• Tableting issues such as sticking and picking, capping, chipping, compressibility, delamination, disintegration, and black spots on surface
• General issues such as machine set-up, machine performance, and documentation.
• 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.

Level 3:

• 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:
• Tableting issues such as sticking and picking, capping, chipping, compressibility, delamination, disintegration, and black spots on surface
• General issues such as machine set-up, machine performance, and documentation.
• 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…