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Compounder ( Weekend Shift)

2 months ago

Lakewood, United States Accupac Full time
Job DescriptionJob DescriptionTitle: Compounder I, II, and III (Weekend Shift)
Location / Department: Manufacturing Department
Reports To: Manager, Manufacturing
FLSA Status: Non-Exempt
________________________________________________________________________

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 Manufacturing 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:
  • Compounder level and compensation will be determined by successful completion and verification of levels in the Compounder Skill Level Chart.
  • Clean and sanitize manufacturing related equipment and utensils.
  • Set-up manufacturing equipment to support a specific manufacturing 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 manufacturing 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 manufacturing 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 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 work in confined spaces.
  • Able to push a 55-gallon 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.
  • Able to wear a tight-fitted negative pressure air-purifying respirator. Employees must be clean shaven with no facial hair to be able to daily use this type of 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 manufacturing environment specifically with chemical handling experience.