Cambridge, MA, USA | Full Time Nanobiosym is an innovative company in Cambridge, MA that is developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. This hypergrowth company allows for unique career opportunities with strong long-term incentives. Nanobiosym is currently seeking top notch candidates to help the company scale up its operations. Nanobiosym is looking for a General Supervisor for its High-Complexity Testing CLIA LAB. The role and requirements are below. The purpose of the Laboratory General Supervisor is to serve as a general supervisor under CLIA 42 CFR 493.1449 regulations for a molecular diagnostics lab. You will assist the Clinical Laboratory Director in day-to-day personnel, workflow, quality control, and equipment management. You are responsible for ensuring that the tests meet all regulatory requirements and coordinating with the laboratory staff to review data for accuracy and issue tests reports in a timely manner. Job Responsibilities:
Provide leadership and directs a team of technologists through positive communication and support
Train new personnel with regard to technical and operational procedures
Ensure all laboratory members are proficient in assay processing including biannual (first year and subsequent annual competency training)
Organize specimens required to be run
Review data for concordant analysis, write-up results, and file data with the assay tested under competency runs
Annually evaluate and document the performance of all testing personnel
Create daily/weekly technologist schedule for molecular diagnostic assays
Setting-up equipment and resources for the laboratory
Monitor examinations to ensure that acceptable levels of analytic performance are maintained and meet TATs
Ensure that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specification
Report quality issues directly to the Clinical Laboratory Director
Track proficiency testing for the validated assay in the laboratory that includes calendar tracking, and following through concordance analysis and finalizing all documents in the database for any future inspections
Maintain all Quality Management System on instrument maintenance programs, i.e. preventative maintenance, cleanliness and maintains records of service in compliance CAP
Maintain and manage daily performance and workload distributed throughout the laboratory
Review issues regarding problem cases with Clinical Laboratory Director to get direction for troubleshooting and next step directions
Work with the lab team to monitor and maintain inventory of supplies, place orders of materials
Participate with Clinical Laboratory Director in managing all governmental and regulatory audits
Mange and monitor Quality Control (QC), Quality Assurance (QA), Safety and Inspection practices to assure compliance with CLIA and MA regulations
Develop, implement and maintain SOPs as per CLIA and MA regulation
Maintain a flexible schedule to meet laboratory goals
Qualifications:
Qualified as a Director for high-complexity testing;
OR Qualified as a Technical Supervisor for high complexity testing;
OR Doctoral degree in clinical laboratory science or chemical, physical or biological science with 1 year training and experience in high-complexity testing;
OR 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;
OR 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;
OR 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 42CFR493.1461 for additional qualifications