Associate I, Quality Control

As a valued member of the Quality Control team, the Associate plays a key role in conducting quality control activities on raw materials, subassemblies and finished goods to support timely Production operations.

**ABOUT BIOLYTICAL**

bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI® technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019 and the Globe and Mail’s Fastest Growing Companies list in 2020. We have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year and have been featured on BC’s Fastest Growing Companies six years in a row. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team.

**HOW YOU WILL CONTRIBUTE**
- Perform incoming raw material and finished goods inspection activities
- Perform INSTI component release testing activities
- Complete QC testing records and update associated tracking logs
- Maintain QC sample inventory and retention
- Coordinate 3rd party laboratory testing in accordance with the Production master schedule
- Prepare and qualify QC standards to support INSTI product testing
- Support Archived Finished Device Testing Program
- Initiate and complete Out-Of-Specification (OOS), Process Deviations Reports (PDR) and Non-Conformity Reports (NCR) related to Quality Control inspection and testing
- Critically analyze test results and participate in investigational testing to support OOS and NCRs
- Support improvement of Product quality Key Performance Indicators (KPIs)
- Participate in investigations to support Customer Complaint Reports (CCR) and Corrective and Preventive Actions (CAPA)
- Review and revise QC documents (SOP’s, WI’s, FRM’s) as required

**WHAT YOU BRING**
- Bachelor’s degree or equivalent in a scientific discipline and/or relevant work experience in the medical device manufacturing industry
- Minimum of two years experience in GMP manufacturing
- Knowledge of working under ISO 13485 requirements preferred
- Experience using basic laboratory equipment (pipettes, balances, calipers)
- Basic reagent preparation experience
- Organized and detail-oriented with strong time management skills
- Excellent interpersonal and communication (written/verbal) skill
- Comfortable working with potentially infectious materials (blood and blood products)
- Flexible availability (night and/or weekend shifts when applicable)
- Experience working in a BSL2 laboratory is an asset
- Experience with 5S, Lean 6 Sigma, and Minitab is an asset
- Knowledge of SDS-PAGE and Western Blot techniques is an asset

**WHAT WE OFFER**
- A competitive compensation package
- Extended health benefits including dental - 100% employer contribution
- Flexible working hours
- Paid sick days
- Bonus day off with pay on your birthday every year
- Full-size in-house fitness gym and shower facilities
- Complimentary reserved parking
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques
- The opportunity to join an ‘off the charts’ foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table

The annual base salary for this job ranges from:
$43,000-$45,000

bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization.

**CORE VALUES**

**INNOVATION**in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.

**NEVER SAY NEVER**: Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.

**SENSATIONAL**to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.

**TAKES OWNERSHIP**of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.

**INSPIRED**to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.

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