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Quality Assurance Specialist: Reagent Quality

2 months ago

Salt Lake, Utah, United States bioMerieux Full time
Job Summary

bioMerieux, a world leader in in vitro diagnostics, is seeking a Quality Specialist to join our Reagent Quality Team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our reagents.

Key Responsibilities
  • Perform quality assurance activities, including reviewing and assessing processes and products to ensure compliance with requirements.
  • Contribute to quality improvement projects, such as CAPAs, training deficiencies, and procedural improvements.
  • Inspect products, including labels, to specifications and established procedures.
  • Identify and escalate non-conformances, working with production teams to resolve issues.
  • Ensure good documentation practices and report inconsistent or incorrect records.
  • Prioritize product release to meet department goals.
  • Review and approve Device History Records.
  • Release finished goods to stock inventory.
Requirements
  • High school diploma or equivalent required; associate degree in a life science or engineering discipline preferred.
  • Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 required.
  • Minimum 1-year previous on-the-job experience requiring professional communication and interactions.
  • Minimum additional 2-year experience in a Quality Assurance, Quality Control, laboratory, or life science setting with a formal quality system.
What We Offer

bioMerieux offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to providing a safe and healthy work environment, and we offer a competitive compensation and benefits package.