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Clinical Laboratory Scientist V- Flow Validation

August 24, 2021

Position Summary: A brief description of the overall primary duties

Has lead responsibility for the development, updating and troubleshooting of Clinical Flow Cytometry assays. Provides oversight of day to day operation of a specialized area and relevant clinical and technical support to staff.

Responsibilities: A listing of the key responsibilities  

  1. Under the Medical Director leadership develop new, update current and suitably validate Clinical Flow Cytometry Assays.
  2. Define and put in place quality control measures for newly developed assays. Oversees all quality control data and maintenance records within section.
  3. Responsible for the generation, training, and adherence to analytical documents such as SOP, Training checklist, etc.
  4. Oversees adequate orientation for new staff, assesses new training needs, and continuing education programs for the Flow section.
  5. Manages competency and proficiency programs within Flow.
  6. Ensures all assays meet regulatory accreditation requirements
  7. With Medical Director Guidance, create an up to date process and procedures for the development and validation of Clinical lab developed tests (LDT).
  8. Oversees the purchasing of needed supplies and reagents for work relating to new or updating of assays.  Monitors cost of supplies against the budget allocations.
  9. Recommends updates and changes to the quality assurance programs as needed.
  10. Evaluates new methodologies, reagents, and instrumentation. Acts as a Clinical and technical resource for staff when needed and provide leadership regarding new developments in the field.
  11. Works in conjunction with Medical Director as a planning resource to the Supervisor and the Department.
  12. Run and result patient testing when additional department support is required.
  13.  Oversees and performs troubleshooting steps necessary to resolve complex technical problems with Analyzers, Assays and Procedures.
  14. May direct and assume the responsibility for the activities of assigned technical staff.
  15. Interacts with manufacturer's representatives and keeps abreast of price variations and new products in the marketplace.
  16. Suggests product changes or new suppliers to Supervisor to improve performance or cost/budget ratio.
  17. Collaborates with team members on process improvement and developing Lean workflows.
  18. Performs other duties as required or assigned.

Minimum Qualifications:

  • Bachelor’s degree with 4 years clinically relevant experience required.
  • Previous Flow assay development and validation work
  • Ability to work independently and adhere to deadlines and manage changing volumes. Basic knowledge of computer software systems.
  • Excellent interpersonal and communications skills, consensus building skills and a team approach required. 

Required Licensure/Certification Skills:

  • MT (ASCP) or equivalent certification required.
  • Certified specialist in the particular area preferred.