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Quality Assurance Specialist

2 months ago

Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time
About the Role

TalentSphere Staffing Solutions is pleased to partner with Augurex Life Sciences to acquire a new Quality Assurance Specialist.

About Augurex

Augurex is a commercial stage diagnostics company dedicated to the early identification and diagnosis of autoimmune disorders, allowing treatment options to be optimized and personalized for patients around the world. Augurex's lead diagnostic test, JOINTstat, is an important tool in the diagnosis and management of inflammatory diseases, including rheumatoid arthritis, lupus and other autoimmune conditions. SPINEstat expands Augurex's biomarker-informed diagnostic portfolio into axial spondyloarthritis (axSpA) and has the potential to bring a novel first-in-class diagnostic to this area of significant unmet medical need.

Why Work with Us

The dynamic, tight-knit team of Augurex employees are tenacious and inclusive and have a passion for seeing our solutions make a difference in people's lives. From the laboratory bench through to clinical development and commercialization, we are building an organization based on our values and a commitment to transform illness to wellness.

Job Summary

We are seeking a Quality Assurance Specialist to be responsible for implementing and maintaining Augurex's electronic Quality Management System (eQMS) in accordance with regulatory requirements, industry standards, internal quality requirements and specifications. The successful candidate will assist in completing the transition to eQMS solution, and will play an important role in championing, administering and maintaining the system across the organization.

Key Responsibilities

  • Support implementation of the electronic Quality Management System (eQMS).
  • Be responsible for administering the Enterprise Quality Management Software.
  • Process and maintain Augurex's production and quality records, including change requests, non-conformances, corrective and preventive actions (CAPA), and general administrative responsibilities.
  • Manage, coordinate and maintain Augurex's training program.
  • Participate in development and revision of standard operating procedures (SOPs), production related documents, and documents related to Augurex Product Development activities.
  • Perform vendor qualification in accordance with Augurex's supplier control programs.
  • Generate analytical reports on quality metrics, non-conformances, and CAPAs.
  • Monitor quality issues and collaborate with cross-functional teams for root cause analysis.
  • Support internal and external QMS audits and ensure timely and effective report/responses to audit findings.
  • Work closely with R&D, product development and operation teams to ensure product quality throughout development and production.
  • Promote a culture of quality within the organization.

Requirements

  • B.Sc. degree or equivalent in a relevant field with 3 or more years of experience in the diagnostics, medical device, or biopharmaceutical industries.
  • Strong knowledge and experience in quality assurance management concepts and methods.
  • Previous experience in administering or implementing an eQMS in the life sciences sectors or other regulated industries is preferable.
  • Superior computer proficiency (MS Office Suite, Adobe Acrobat or equivalent); aptitude and desire to learn new computer applications.
  • Exceptional communication and teamwork skills.
  • Collaborative worker with an ability to support a high performing team.
  • Familiarity with ISO 13485 is an asset.

What We Offer

  • Proximity to SkyTrain and bike routes.
  • Free parking near by.
  • Teambuilding Company Events.
  • Extended Healthcare Benefits.
  • Flexible schedule.
  • On-site gym.
  • Professional Development Support.