Compounder - Manufacturing Operations

6 days ago

Lakewood, New Jersey, United States Accupac Full time
Job Description

Accupac is seeking a highly skilled Manufacturing Compounder to join our team at our Lakewood, NJ location.

Key Responsibilities:
  • Manufacture customer products by following written instructions and adhering to standard operating procedures (SOPs) and FDA's Current Good Manufacturing Practices (cGMP) regulations.
  • Interpret and execute written instructions to produce bulk products that meet customer specifications.
  • Clean and sanitize manufacturing equipment and utensils to maintain a safe and efficient work environment.
  • Set up manufacturing equipment to support specific operations and ensure proper functioning.
  • Scan labor activities into the central computer system and document relevant activities in equipment logbooks.
  • Verify equipment suitability, cleanliness, and sanitation, as well as raw material information and batch card accuracy.
  • Advise supervisors of any raw material nonconformances and set aside materials for final disposition.
  • Follow customer instructions and report process deviations to immediate supervisors.
  • Coordinate with Quality Assurance to sample completed bulk products.
  • Prepare bulk storage tanks for new product receipts and participate in unloading processes.
  • Monitor manufacturing systems daily and provide routine DI Water samples to the Quality Assurance Laboratory.
  • Perform minor preventative maintenance tasks on equipment and schedule routine cleaning and painting of manufacturing areas and equipment.
  • Interact promptly and courteously with all Accupac employees and visitors.
  • Perform all tasks in a safe and efficient manner.
Requirements:
  • Knowledge of written and spoken English sufficient for internal communication.
  • Ability to follow instructions and understand SOPs, cGMP's, and communicate their requirements to others.
  • Ability to judge equipment cleanliness and sanitation.
  • Working knowledge of tools, hardware, and basic machinery operation, with ability to perceive and fit together different size and shape parts correctly.
  • Ability to work with solvents and chemicals needed for compounding tasks.
  • Ability to work with hot water safely.
  • Able to work different scheduled hours/shifts/days and overtime to meet manufacturing schedules.
Physical Requirements:
  • Able to sustain a minimum of one hour of strenuous activity.
  • Able to lift 50 pounds from the floor to waist level.
  • Able to carry a container weighing up to 50 pounds 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 periods.
  • 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.

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