Clinical Laboratory Supervisor - QA
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Clinical Laboratory Supervisor - QA

Glen Allen, VA

At GENETWORx Laboratory, we improve the health and wellness of lives around the world through dedicated research, experienced scientists, 21-st century technology, and in-depth diagnostics. Healthcare is personal and as such, the future needs to be, too. By intersecting genetic testing with personalized medicine and pharmacogenomics, we’re positioning our patients and empowering physicians with more precise, individualized, effective results.
As a leader in precision COVID-19 testing, GENETWORx provides unparalleled support, results, and clarity during these uncertain times. GENETWORx has armed healthcare providers, employers and universities with rapid and accurate COVID-19 diagnostic and antibody testing which is essential for reopening businesses and communities.

Summary

The Clinical Laboratory Supervisor oversees all quality aspects of remote locations (Collection Sites, Waived Sites, Mobile Units, etc.) to ensure compliance with all CLIA, CAP, State and Federal Regulations. The Clinical Laboratory Supervisor provides technical expertise, support and supervision from a Quality standpoint in the areas of writing procedures, establishing technical policies, continuous quality improvement, inspection readiness, technical education of staff and regulatory compliance.

Responsibilities

  • Supervises, directs, plans, develops, implements, evaluates, and oversees the execution of all Quality aspects of Specimen Collection and Testing
  • The Clinical Lab Supervisor must be accessible to the remote locations as needed for on-site, telephone, or electronic consultation
  • Maintains current, in-depth, and working knowledge of all accreditation standards including CAP/CLIA, NYS and others, as necessary
  • Provide quality direction and support for initiatives driven by Quality Excellence
  • Serves as a resource to the Laboratory Staff and facilitates comprehension of accreditation standards and regulations
  • Assist with resolution of operational and process problems regarding Quality Assurance issues
  • Ensure that non-conformity events are investigated, corrective actions are implemented, and incidents are resolved closed in a timely manner
  • Assist and participates in all accreditation inspections
  • Conducts internal audits and compiles reports stating improvement for findings, implements improvement plans and follows up to assure compliance
  • Works with Laboratory Staff to identify events
  • Aids in writing and reviewing documents such as SOP’s and training checklist
  • Review and approve qualification and assessment protocol and reports
  • Working knowledge of QC and analytical test methods
  • Responsible for the completion of any special projects and process improvements at the request of the Director and/or the Quality Lab Manager

Qualifications

  • Previous knowledge and experience with Laboratory Quality Assurance and Quality Control requirements
  • At a minimum, a bachelor’s degree in a chemical, physical, molecular, biological, or clinical laboratory science or medical technology with at least five (5) years of experience in a Clinical or Molecular Laboratory
  • Excellent working knowledge of regulatory and accreditation requirements
  • A high degree of technical and decision-making skill

Compensation: TBD

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