Compounder Assistant - Accupac

Basic Job Functions:
Responsible for assisting the Manufacturing Compounders with routine tasks associated with the manufacture of bulk products and with the housekeeping of the Manufacturing Department. The Manufacturing operation is performed in a manner that complies with Accupac's SOP and the FDA's Good Manufacturing Practices regulations.

Essential Functions of the Job:

• Stage pre-weighed raw materials in designated manufacturing areas.
• Set-up manufacturing equipment to support a specific manufacturing operation.
• Assist the Compounders in the addition of raw materials to products being manufactured.
• Remove empty raw material containers (bags, drums, gaylords, super sacks, etc.) from the manufacturing area.
• Weigh drums of finished bulk product.
• Barcode ticket weighed drums of finished bulk product.
• Assist in the changeover of the manufacturing equipment.
• Assist in the cleaning and painting of the manufacturing area and equipment.
• Receive bulk deliveries of raw materials or bulk products.
• Clean and sanitize manufacturing related equipment and utensils.
• Verify that the manufacturing equipment is suitable for its intended use and that it has been cleaned & sanitized.
• Scan all labor activities into the central computer system.
• Document all relative activities associated to the batch in respective equipment logbooks.
• Verify 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.
• 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.
• Able to drive a forklift — have current forklift certification.
• Interface promptly and courteously with all Accupac 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 Standard Operating Procedures, 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 manufacturing 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 push a 55 gallon drum full of bulk product up to six feet
• Able to work in confined spaces.
• Possess the ability to stand on concrete floors for full shift period
• Able to perform repetitive movements.
• Able to move physically 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
• Able to wear a half-face negative pressure air-purifying 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. Prefer experience working in a manufacturing environment specifically with chemical handling experience.