Lead Supervisor for Advanced CLIA Laboratory

2 months ago

Cambridge, Massachusetts, United States Nanobiosym Full time
Position Overview

Nanobiosym is a pioneering organization located in Cambridge, MA, dedicated to creating innovative solutions for a wide array of health challenges. Founded by an alumnus of MIT and Harvard, the company operates at the cutting edge of physics, nanotechnology, and biomedicine. As a rapidly expanding enterprise, we offer exceptional career pathways complemented by robust long-term incentives.


We are currently in search of a Lead Supervisor for our High-Complexity Testing CLIA Laboratory. This role is essential for ensuring compliance with CLIA 42 CFR regulations in a molecular diagnostics environment. The General Supervisor will collaborate closely with the Clinical Laboratory Director to oversee daily operations, personnel management, workflow optimization, quality assurance, and equipment oversight.


Key Responsibilities:

  1. Provide effective leadership and guidance to a team of laboratory technologists through constructive communication and support.
  2. Train new staff on technical and operational protocols.
  3. Ensure all laboratory personnel are competent in assay processing, including biannual competency evaluations.
  4. Organize and manage specimens required for testing.
  5. Review analytical data for accuracy, document results, and ensure timely reporting.
  6. Conduct annual performance evaluations for all testing staff.
  7. Create and manage daily and weekly schedules for technologists performing molecular diagnostic assays.
  8. Set up laboratory equipment and resources efficiently.
  9. Monitor testing processes to maintain acceptable levels of analytical performance and turnaround times.
  10. Implement corrective actions for any deviations from established performance standards.
  11. Report quality concerns directly to the Clinical Laboratory Director.
  12. Track proficiency testing for validated assays, ensuring compliance with regulatory requirements.
  13. Maintain the Quality Management System, including instrument maintenance and service records.
  14. Oversee daily laboratory performance and workload distribution.
  15. Collaborate with the Clinical Laboratory Director to address complex case issues and determine troubleshooting strategies.
  16. Work with the laboratory team to manage inventory and order necessary supplies.
  17. Assist the Clinical Laboratory Director in preparing for regulatory audits.
  18. Manage Quality Control (QC), Quality Assurance (QA), and safety practices to ensure compliance with CLIA and state regulations.
  19. Develop, implement, and maintain Standard Operating Procedures (SOPs) in accordance with regulatory standards.
  20. Maintain a flexible schedule to achieve laboratory objectives.

Qualifications:

  1. Qualified as a Director for high-complexity testing.
  2. OR Qualified as a Technical Supervisor for high-complexity testing.
  3. OR Doctoral degree in clinical laboratory science or a related field with one year of training and experience in high-complexity testing.
  4. OR Master's degree in clinical laboratory science, medical technology, or a related field with one year of training and experience in high-complexity testing.
  5. OR Bachelor's degree in clinical laboratory science, medical technology, or a related field with one year of training and experience in high-complexity testing.
  6. OR Associate degree in medical laboratory technology with two years of relevant training or experience in high-complexity testing.

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