Full-time Position

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Position Overview:

Helps oversee all Quality aspects of remote locations (Collection Sites, Waived Sites, Mobile Units, etc.) to ensure compliance with all CLIA, CAP, State and Federal Regulations. 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.

 

Specific Responsibilities:

  • Supervises, directs, plans, develops, implements, evaluates, and oversees the execution of all Quality aspects of Specimen Collection and Testing.
  • The Quality 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 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.
  • Ability to look beyond daily functions to implement higher standards through evaluation
  • Ability to manage multiple priorities with aggressive timelines
  • Excellent written, verbal communication and technical writing skills.
  • Strong interpersonal skills and ability to work in a matrix team environment
  • Strong problem solving, conflict resolution, negotiation and independent quality decision making skills.
  • Strong ability to coach/mentor and is self-directed.
  • Strong leadership and decision-making skills; ability to communicate ideas, opinions and counter arguments in a proactive and professional manner.
  • Assist with Other Duties as assigned

 

 

 

 

 

Education and Experience

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

 

Competencies:

 

Work Environment: May work in a variety of laboratory environments at Biosafety Levels I or II.

 

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 required

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