Compounder

Basic Job Functions:

The Compounder is responsible for manufacturing a customer’s product by following a set of written instructions. This activity involves the interpretation and execution of written instructions that results in a bulk product that conforms to the customer’s specifications. The compounding operation is performed in a manner that complies with Accupac’s standard operating procedures (SOPs) and the FDA’s Current Good Manufacturing Practices (cGMP) regulations.

Essential Functions of the Job:

• Participation & passing of Compounder Trainee Program which includes onthejob training and a individual peer trainer
• Compounder level and compensation will be determined by successful completion and verification of levels in the Compounder Skill Level Chart.
• Clean and sanitize compounding related equipment and utensils.
• Setup compounding equipment to support a specific compounding operation.
• Scan all labor activities into the central computer system.
• Document all relative activities associated to the batch in respective equipment logbooks.
• Verify that the compounding equipment is suitable for its intended use and that it has been cleaned & sanitized.
• Verify that the information on the raw material Barcode Tickets and the manufacturing batch card are in agreement and have not expired.
• Advise direct supervisor of any raw material information nonconformance and set the material aside for final disposition.
• Follow the customer’s written instructions. Advise the immediate supervisor of all process deviations.
• Advise the Quality Assurance Group when they can sample the completed bulk product.
• Prepare bulk storage tanks for new product receipts. Participate in the unloading process of the receipt.
• Perform the daily monitoring of manufacturing systems.
• Provide the Quality Assurance Laboratory with routine DI Water samples.
• Perform minor preventative maintenance tasks on the equipment.
• Perform the scheduled / routine cleaning and painting of the compounding area and equipment.
• Interface promptly and courteously with all Accupac, Inc. employees and visitors.
• Perform all jobs in a safe and efficient manner.
• Perform all other duties as assigned.

Minimum Requirements of the Job:

• Knowledge of written and spoken English sufficient for internal communication
• Ability to follow instructions.
• Ability to understand SOPs, cGMP's and communicate their requirements to others.
• Ability to judge when equipment has been thoroughly cleaned and sanitized.
• Working knowledge of tools, hardware, and basic machinery operation with ability to perceive different size and shape parts, and fit them together, correctly.
• Ability to work around solvents and chemicals needed for compounding tasks.
• Ability to work with hot water ( / 180 degrees F) safely.
• Able to work different scheduled hours/shifts/days and overtime to meet the compounding schedule.

Physical Requirements:

• Able to sustain a minimum of one (1) hour of strenuous activity.
• Able to lift 50 lbs. from the floor to waist level.
• Able to carry a container weighing up to 50 lbs. up a flight of stairs.
• Able to push or pull weights up to 50 pounds.
• Able to work in confined spaces.
• Able to push a 55gallon drum full of bulk product up to six feet.
• Possess the ability to stand on concrete floors for full shift period.
• Able to perform repetitive movements.
• Able to physically move containers “off of” and “on to” pallets.
• Able to work with a pallet jack.
• Possess the physical mobility to reach overhead and bend at and below waist level.
• Able to work at heights up to 20 feet.
• Possess manual dexterity to unfasten and fasten large and small parts using hand tools.
• Possess the ability to hear speech and/or alarms through plant noise.
• Possess peripheral vision.
• Possess eyesight with or without corrective lenses to discern differences in small type characters for coder set ups.
• Possess the ability to recognize colors and shades of color.
• Be able to obtain preemployment medical clearance to wear a respirator
• Able to pass the PFT test and physical examination.
• Able to work in a “dusty” environment.
• Able to work outside for up to 20% of the workday.
• Able to work with chemicals and solvents used for sanitizations. Must not be allergic to chemicals and solvents used for sanitizations.

Supervisory Responsibilities: No

Travel: None

Education and/or Experience: Must have a high school diploma or GED, college course-work preferred. Prefer 2 years-experience working in a compounding environment specifically with chemical handling experience.