Senior Laboratory Supervisor

3 days ago

Cambridge, Massachusetts, United States Nanobiosym Full time
Job Summary

Nanobiosym is seeking a highly skilled and experienced General Supervisor to lead its High-Complexity Testing CLIA LAB. The successful candidate will be responsible for ensuring the laboratory meets all regulatory requirements, coordinating with staff to review data for accuracy, and issuing test reports in a timely manner.

Key Responsibilities
  1. Provide leadership and direction to a team of technologists through positive communication and support.
  2. Train new personnel on technical and operational procedures.
  3. Ensure all laboratory members are proficient in assay processing, including biannual competency training.
  4. Organize specimens required to be run.
  5. Review data for concordant analysis, write-up results, and file data with the assay tested under competency runs.
  6. Annually evaluate and document the performance of all testing personnel.
  7. Create daily/weekly technologist schedules for molecular diagnostic assays.
  8. Set up equipment and resources for the laboratory.
  9. Monitor examinations to ensure acceptable levels of analytic performance are maintained and meet TATs.
  10. Ensure all remedial actions are taken when test systems deviate from the laboratory's established performance specification.
  11. Report quality issues directly to the Clinical Laboratory Director.
  12. Track proficiency testing for the validated assay in the laboratory, including calendar tracking and concordance analysis.
  13. Maintain all Quality Management System on instrument maintenance programs, including preventative maintenance, cleanliness, and records of service in compliance with CAP.
  14. Maintain and manage daily performance and workload distributed throughout the laboratory.
  15. Review issues regarding problem cases with the Clinical Laboratory Director to obtain direction for troubleshooting and next steps.
  16. Work with the lab team to monitor and maintain inventory of supplies, place orders for materials.
  17. Participate with the Clinical Laboratory Director in managing all governmental and regulatory audits.
  18. Manage and monitor Quality Control (QC), Quality Assurance (QA), Safety, and Inspection practices to ensure compliance with CLIA and MA regulations.
  19. Develop, implement, and maintain SOPs as per CLIA and MA regulations.
  20. Maintain a flexible schedule to meet laboratory goals.
Qualifications
  1. Qualified as a Director for high-complexity testing.
  2. Qualified as a Technical Supervisor for high-complexity testing.
  3. Doctoral degree in clinical laboratory science or chemical, physical, or biological science with 1 year training and experience in high-complexity testing.
  4. Master's degree in clinical laboratory science, medical technology, or chemical, physical, or biological science and 1 year training and experience in high-complexity testing.
  5. Bachelor's degree in clinical laboratory science, medical technology, or chemical, physical, or biological science and 1 year training and experience in high-complexity testing.
  6. Associate degree in medical laboratory technology (or pulmonary function) and 2 years laboratory (or blood gas analysis) training or experience, or both, in high-complexity testing. Refer to the CLIA regulation 42 CFR 493.1461 for additional qualifications.

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