Overview

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

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ABOUT BIOLYTICAL:

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.

SUMMARY:

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.

ROLE AND RESPONSIBILITIES:

· 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

REQUIREMENTS:

· 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

SKILLS:

· 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

HOW TO APPLY:

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

Education:

  • Bachelor’s Degree (Required)

About the Company

Company: bioLytical Laboratories

Company Location:  Richmond, BC

Estimated Salary:

About bioLytical Laboratories