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Lead Supervisor for Advanced CLIA Laboratory

2 months ago

Cambridge, Massachusetts, United States Nanobiosym Full time
Position Overview

Nanobiosym is a pioneering organization focused on developing cutting-edge technologies to combat a wide array of health challenges. With roots in prestigious institutions, we are at the forefront of innovation, merging physics, nanotechnology, and biomedicine. Our rapid growth offers exceptional career paths with significant long-term benefits.


We are currently in search of a Lead Supervisor for our High-Complexity Testing CLIA Laboratory. This role is crucial for overseeing operations in compliance with CLIA 42 CFR regulations within a molecular diagnostics setting. The selected candidate will collaborate closely with the Clinical Laboratory Director to manage daily activities, personnel, workflow, 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. Facilitate training for new staff on technical and operational protocols.
  3. Ensure proficiency among laboratory personnel in assay processing, including regular competency evaluations.
  4. Organize and manage specimens for testing.
  5. Review analytical data for consistency, 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 involved in molecular diagnostics.
  8. Oversee the setup of laboratory equipment and resources.
  9. Monitor testing processes to maintain acceptable analytic performance levels 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. Manage daily laboratory performance and workload distribution.
  15. Collaborate with the Clinical Laboratory Director to address complex case issues and determine troubleshooting steps.
  16. Work with the laboratory team to monitor inventory levels and manage supply orders.
  17. Assist in preparing for and managing governmental and regulatory audits.
  18. Oversee 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. Adapt work schedule as necessary 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 related fields with relevant training and experience.
  4. OR Master's degree in clinical laboratory science or related fields with relevant training and experience.
  5. OR Bachelor's degree in clinical laboratory science or related fields with relevant training and experience.
  6. OR Associate degree in medical laboratory technology with significant training or experience in high-complexity testing.