Operator I

Role Summary

The Operator is responsible for the set-up, operation, routine maintenance, and cleaning of Encapsulation/Compression/Coating department’s equipment in accordance with applicable cGMPs and SOPs. The Operator possesses all of the skills and competencies that are required and also has completed the necessary training. Shift Hours: M-F 3:15pm-11:45pm.

Responsibilities

• Set up Encapsulation/Compression/Coating equipment and machinery in preparation for the shift
• Perform required Encapsulation/Compression/Coating duties including running Encapsulation capsule filler, capsule polishers, floor scale, desk balance, capsule feeder, metal checkers, capsule weighing system, moving drums etc. Compression tablet press, metal checker, tablet tester, hardness tester, desk balance and floor scale. Coating accela coater, compu-lab coater, floor scale, desk scale. Here are the details:
  • Fiber drums are transferred onto a drum lifter and pulled into capsule rooms as needed (147 lbs.approx. of pulling force required).
  • Product is scooped into hoppers as needed (5 lbs. approx. per scoop)
  • Empty capsule boxes are pulled into the room as needed (32 lbs.) approx...
  • Empty capsules are dumped into the Capsule Feeder hopper (32 lbs.) on a continual basis daily as needed.
  • Bags are filled with capsules and put into fiber drums (14-22 lbs. per bag). Fiber drums that are filled weigh approximately 147 lbs. but they are rolled not lifted onto a skid.
  • Machine parts are lifted once a month to be vacuumed out (7-70 lbs.)
  • Storage boxes for machine parts are lifted onto a cart and taken to capsule rooms as needed (70 lbs.) regularly 1-3 times a week.
  • Vacuum canister is emptied and cleaned after every batch. Canister weighs 14 lbs. plus the weight of product which varies depending on waste.
• Fill out all batch record information and other encapsulation paperwork.
• Clean equipment and facilities.
• Perform product sampling.
• Warehousing of product – incoming and outgoing.

Qualifications

• Required: High school diploma or GED
• Required: Equivalent combination of education, training and related experience will be considered
• Required: Knowledge of applicable SOPs and cGMPs
• Required: Knowledge of Manufacturing Department procedures
• Required: Physical ability to lift/move up to 40 lbs
• Required: Not allergic to cephalosporins, chemicals or biosubstances found in laboratories or production facilities

Education

• Required: High school diploma or GED
• Equivalent combinations of education, training and related experience will be considered