Production Assembler

6 months ago

Kanata, Canada Evik Diagnostic Innovations Full time

Production, Assembler

Evik Diagnostics Innovations is an Ottawa based ISO 13485:2016 certified manufacturer of freeze-dried chemical reagent beads for point-of-care, life sciences, environmental monitoring, and medical device manufacturers. We are an expanding start-up company, research laboratory and biotechnology manufacturer, dealing with production quantities ranging from as little as 1000 beads to as many as 150,000 beads per day.

Reporting to the production supervisor, employees in this position perform inspection tasks on finished beads, manually assemble medical device and life sciences cartridges of varying sizes and configurations, and package beads into small vessels such as PCR tubes and 96-well plates. They are responsible for following SOPs, work instructions, and completing batch records. Since they will be working with components of medical devices, they must be conscious of contamination control and are responsible for maintaining a clean workspace. This work is of a precise nature and is performed within a controlled environment where temperature, humidity and contamination are closely monitored.

KEY RESPONSIBILITIES
- Adheres to current good manufacturing practices, and standard operating procedures, to maintain a safe and clean work environment.
- Use various production and lab equipment including, but not limited to, tweezers, automated heat sealers, metal bead droppers, analytical balances, graduated cylinders, and other customer specific tooling. Some assembly takes place within a sealed laboratory glovebox.
- Ensure all equipment used is within calibration and is functioning properly.
- Assemble customer cartridges of varying design.
- Package lyophilized reagent beads in various formats including, but not limited to, PCR strip tubes, 96-well plates, microcentrifuge tubes and customer-specific cartridges.
- Perform in-process visual inspection of freeze-dried chemical reagent beads and other products to identify non-conforming or damaged products.
- Maintain accurate batch records and documentation according to the Quality Management System.
- Maintain a contamination-free workspace and wear appropriate PPE when required.
- Wash labware as scheduled according to specific work instructions.
- Other duties as assigned and deemed appropriate for this position.
- Supports improvements to the production team by providing feedback on equipment, processes, and products and providing training to other employees.

SKILLS AND QUALIFICATIONS
- High School diploma or equivalent.
- Additional relevant technical training certificates and/or College diplomas will be considered an asset.
- Experience working in a laboratory environment or with medical devices will be considered an asset.
- Proven English language communication skills both written and spoken.
- Dedication to production quality and deadlines.
- Adaptable to rapidly changing plans and deadlines.
- Good eyesight and hand / eye coordination with meticulous attention to detail.
- Ability to work with small and delicate equipment and products.
- Ability to perform repetitive tasks.
- Responsible, dependable and with a strong work ethic
- Ability to work independently and as a small team.

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