Job Summary
Reporting to the Production Supervisor, the Non-Sterile Machine Operator is responsible for ensuring product meets quality standards during packaging operations by operating equipment and packing product in compliance with cGMP and SOP requirements.
Job Duties
* Works in compliance with established Standard Operating Procedures (SOPs) and safety policies. Completes all required GMP documentation in an accurate and timely manner according to procedures. Initials and dates any errors.
* Wears required personal protection and follows company safety rules. Reports any accidents, incidents and injuries or illnesses immediately and notifies Supervisor of any hazards, unsafe acts or conditions in the workplace.
* Keeps packaging operations stocked by loading syringes into hopper for filling, obtaining packaging components for assembly or other materials/labels used. Operates a pallet lift to move components as needed.
* Inspects bottles and syringes after being filled to ensure they meet specifications at each step of the packaging process. Pulls defective items and documents on checklists or dockets any out-of-spec incidents. Calculates % rejected after visual inspection completed for the lot#.
* Pulls a certain number of samples according to schedule to document fill volumes. Measures volume of product and records on the docket. Calculates average volume of samples pulled to ensure it meets fill volume specs.
* Monitors operation of the labelling and cartoning machines to ensure steady operation and accuracy of exp date printing. Starts, stops, and regulates speed of conveyor as needed. Changes label cartridges and troubleshoots minor problems.
* Assembles cartons, labels them and places product into box. Seals cases and loads them on pallets. Delivers full pallets to receiving area using pallet lift.
* Communicates problems or OOS incidents with Lead Hand and/or Supervisor for resolution.
* Cleans and tidies packaging area as needed.
* Other duties as assigned.
Technical/Physical & Behavioural Abilities
* 1 – 3 years experience, preferably in a GMP pharmaceutical packaging & manufacturing facility.
* High School Diploma required.
* Excellent math skills. Good command of the English language, verbal, reading and writing.
* Strong hand-eye coordination. Able to lift and move up to 10lbs and occasionally up to 30lbs, visual acuity; good manual dexterity; some repetitive movements.
* High integrity, flexibility in working overtime, responsible, reliable, with good attention to details, good problem-solving skills.
* Ability to work effectively independently and as part of a team.
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.
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