Quality Control (QC) Associate Job at bioLytical Laboratories in Richmond, BC

Job Description

Quality Control (QC) Associate
Department: Quality and Regulatory

Location: Richmond, BC, Canada
Position: Permanent, Full-Time



Biolytical Laboratories Inc. based in Richmond, BC, Canada is a privately-owned Canadian Company federally incorporated in 2002 and focused on the research, development, and commercialization of rapid, point-of-care in vitro medical diagnostics developed using its proprietary INSTI™ technology platform. Today, the company sells and markets its INSTI™ HIV test and has a world-wide footprint of regulatory approvals including US FDA approval, Health Canada approval and CE mark. Our product provides a highly accurate HIV test result in as little as 60 seconds which translates into a compelling value proposition for patients, healthcare professionals, and public health organizations.


As a valued member of the Quality team, the QC Associate plays a key role in conducting quality control activities to support Production timelines. This position reports to the Quality Control Manager, under the supervision of the VP, Quality and Regulatory.


· Perform incoming verification and inspection activities for raw materials against established quality specifications

· Perform inspection of INSTI components and finished devices

· Complete QC testing records and update associated tracking logs

· Maintain QC sample inventory and retention

· Coordinate 3rd party laboratory testing in accordance to 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

· Train new QC personnel on QC activities and requirements as required


· Bachelor degree or equivalent, preferably in a scientific discipline and /or relevant work experience in medical device manufacturing industry

· Minimum of two years experience in GMP manufacturing

· Knowledge of working under ISO 13485 requirements preferred


· Strong analytical skills and critical thinking

· Comfortable in a fast-paced environment

· Experience using basic laboratory equipment (balances, calipers, pipette)

· Basic Reagent preparation experience

· Organized and detail-oriented

· Strong time-management skills, including ability to handle multiple tasks simultaneously

· Excellent computer skills (MS Office, Access, Excel)

· Excellent interpersonal skills

· Excellent written/verbal communication skills

· Comfortable handling biological specimens

· Experience with SDS-PAGE and Western Blot analysis, an asset

· Knowledge of Lean Six Sigma, an asset


bioLytical Laboratories Inc. offers a challenging, enriching work environment and competitive compensation commensurate with experience.

We are an equal opportunity employer and invite applications from all qualified individuals.

Job Type: Full-time


  • Bachelor’s Degree (Required)

About the Company

Company: bioLytical Laboratories

Company Location:  Richmond, BC

Estimated Salary:

About bioLytical Laboratories