Quality Technical Specialist
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Quality Technical Specialist

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

Under the supervision of the Laboratory Quality Manager, the Quality Technical Specialist will support new market development efforts. This position will complete due diligence for any new Laboratory Projects or Initiatives. This position will research industry best practices within the service line and provide recommendations regarding project development and operational development. The Quality Technical Specialist will provide technical expertise and support from a Quality standpoint in the areas of writing procedures, research and development, establishing technical policies, continuous quality improvement, technical education of staff and regulatory compliance.

Responsibilities

  • Oversees technical research and development under the direction of the Quality Manager/Director. Works hand in hand with the Laboratory Research and Development Team.
  • Participates in the evaluation and selection of new procedures and instrumentation. Assists in reviewing new procedures and policies. Reviews and standardizes procedures between testing sites where applicable.
  • Focus on quality by working with Laboratory Departments in the development and implementation of QC and QA policies and procedures. Participates in CQI projects and outcome measurement studies. Reviews plans ad reports for all technical verification or validation studies. Ensures that regulatory and compliance standards are met.
  • Works with the Quality Manager and Laboratory Director to provide technical staff development within their technical specialty.
  • Participates in the implementation of New Projects and Initiatives.
  • Serves as a system technical resource. Provides technical support for problem solving.
Go Live Readiness

  • Participate in GENETWORx Readiness activities
  • Provide real time support of go lives
  • Ensure all areas of quality go live requirements have been completed at minimum 30 days prior to go live
  • Development of Quality monitoring tools
  • Development of quality reporting and compliance analytics

Qualifications

  • Bachelor’s Degree in a chemical, physical, biological or clinical laboratory science or medical technology. Qualifies as a Technical Supervisor as defined under CLIA '88.
  • Bachelor’s Degree in Molecular Diagnostics Preferred.
  • Five (5) years’ of training and experience in high complexity Molecular Microbiology testing preferred
  • Previous experience in Laboratory Project Development and Implementation
  • Excellent working knowledge of regulatory and accreditation requirements.
  • A high degree of technical and decision-making skills.

Work Environment

May work in a variety of laboratory environments at Biosafety Levels I or II. They spend much of their time on their feet, actively working with patient samples on complex equipment.

Physical Demands

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands to finger, handle or feel objects, tools or controls. The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move objects up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision and the ability to adjust focus.

Travel

Work related travel will be minimal.

Compensation: TBD

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