Quality Control Specialist

bioLytical Laboratories - Richmond, BC (29 days ago)

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ABOUT BIOLYTICAL

Did you know that you no longer have to book an appointment with your doctor and wait weeks to get lab results back for STIs like HIV and Syphilis?

bioLytical’s INSTI is the world’s fastest testing platform – providing results in just 1 minute. Yes, you read that correctly – results in 1 minute not 1 to 2 weeks! We’ve been in business since 2002 and have recently been growing like crazy with the launch of new products all over the world. bioLytical Laboratories has ranked on Business in Vancouver’s Top 100 Fastest Growing Companies list two years in a row and is the winner of the 2018 Lifesciences BC’s Growth Stage MedTech Company of the Year.

The full suite of INSTI tests are greater than 99% accurate and have a world-wide footprint of regulatory approvals including US FDA, Health Canada, World Health Organization Prequalification and CE mark for Europe. bioLytical markets its HIV point-of-care tests, HIV self-tests and dual HIV/Syphilis Multiplex point-of-care tests globally with a strong product pipeline from our research team. INSTI is the world’s fastest test, which means more people tested, more people diagnosed, and more people linked to care.

We are looking for agile and energetic people to join us on our mission to end AIDS. With millions of tests already sold, INSTI is trusted by healthcare professionals and recently available to consumers. Come join us on our journey and help make a difference in the world!

Summary

As a valued member of the Quality Control team, the QC Specialist will play a key role in executing investigations into quality related issues including working with internal cross-departmental teams to troubleshoot these issues and providing ideas for process improvements. The QC Specialist will also conduct routine quality control testing activities to support production timelines. This position reports to the Quality Control Manager.

Role & Responsibilities

  • 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 and ensure completion in a timely manner
  • Participate in investigations to support Corrective and Preventive Actions (CAPA)
  • Review and revise QC documents (SOP’s, WI’s, FRM’s) as required
  • Assist QC team in routine inspection activities for raw materials, in-process and finished goods inspections against established quality specifications
  • Document all work performed according to applicable Good Document Practices (GDPs)
  • Responsible for maintaining QC sample inventory and retention
  • Assist in bioLytical’s internal audit program
  • Provide training to other members of the QC team as required
  • Work with QA and Product Support teams to implement process improvements.

Qualifications

  • Bachelor of science degree in a scientific discipline and/or relevant work experience
  • At least 3 years’ quality control experience preferably in medical device manufacturing industry or GMP manufacturing
  • Willingness to take initiative and solve problems creatively and efficiently to address any quality control issues and contribute to product enhancements
  • Well-developed written & verbal communication and technical documentation skills
  • Demonstrated ability to operate independently with minimal direction in addition to working collaboratively with the team
  • Excellent attention to detail and record keeping skills
  • Ability to handle multiple assignments in a fast-paced environment
  • Comfortable handling biological specimens
  • The flexibility and adaptability to take on additional responsibilities as needed to achieve the team’s goals
  • Ideally knowledge of ISO 13485 and MDSAP requirements
  • Ideally knowledge of 5S & Lean initiatives

WHAT WE OFFER

  • A competitive compensation package
  • Extended health benefits including dental, optometry, RMT, etc.
  • Flexible working hours
  • Paid vacation
  • Bonus day off WITH pay on your Birthday every year!
  • Paid sick days
  • Complimentary shuttle to/from the office and River Rock Hotel
  • Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun

bioLytical is an equal opportunity employer

Job Type: Full-time

Experience:

  • quality control: 3 years (Preferred)