Basic Function and Scope of Responsibility:
Transplant Genomics Inc. (“TGI”) is a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by biomarkers. TGI’s product portfolio of both individual and combined whole blood gene expression and donor derived cell-free DNA testing is capable of reliably ruling out subclinical kidney rejection and acute rejection in kidney transplant patients. In addition to kidney transplantation testing, our newest product for liver transplant patients is a blood-based biomarker assay designed to rule out rejection as immunosuppression therapy is optimized.
The Clinical Laboratory Scientist (CLS) performs laboratory testing, preventive maintenance, troubleshooting, calibration of equipment, quality control procedures and is responsible for the validity of test results with a high level of proficiency and in accordance with Eurofins Transplant Genomics standard operating procedures.
Essential Job Duties:
• Examine samples for validity and other requirements (sample type, volume, etc.)
• Perform sample preparation steps which may include specimen pipetting with a high degree of accuracy and precision
• Operate, calibrate and maintain all assigned laboratory equipment and instruments according to standard operating procedures to ensure quality results
• Perform reagents and materials preparation for testing
• Maintain adequate inventory of supplies, reagents and materials needed for testing
• Document remedial action, troubleshooting, quality assurance activities and instrument maintenance
• Adhere to established processing timelines
• Perform data entry into the Laboratory Information Management System (LIMS)
• Label samples and deliver them to proper area(s)
• Retrieve and re-file samples for testing
• Properly store specimens for short term and long term storage
• Aid laboratory personnel in cleaning duties
• Adhere to all quality and safety standards, as well as ensuring compliance with all applicable regulatory agencies
• Adhere to policies and protocols in the lab
• Work closely and communicate with other lab associates to complete daily activities efficiently
• Represent department and the organization favorably and in accordance with established Company standards and associate attributes at all times
• Other duties as assigned by management
Level I CLS – Minimum Requirements:
• Perform laboratory assays in accordance with standard operating procedures
• Operate, calibrate and maintain all laboratory equipment and instruments according to standard operating procedures to ensure quality results
• Maintain adequate inventory of supplies, reagents and materials
• Accept or reject test results in accordance with standard operating procedures
• Document remedial action, troubleshooting, quality assurance activities and instrument maintenance
• Adhere to established processing timelines
• Adhere to all quality and safety standards
• Other duties as assigned by management
Level II CLS – Minimum Requirements:
• General knowledge of Standard Operating Procedure writing, assay theory, and instrumentation
• Orient, mentor and teach clinical laboratory methods, procedures and techniques to new Associates
• Demonstrate effective teamwork skills by knowledge sharing
• Take on formally-assigned additional duties, such as training, as a part of routine job performance
• Participate on special project teams as requested by supervisory staff
Level III CLS– Minimum Requirements:
• Obtain advanced knowledge of standard operating procedures, assays, and instrumentation
• Participate in troubleshooting activities in conjunction with Technical Supervisor
• Volunteer to serve on various committees and panels to the benefit of the laboratory or company in general (e.g. Safety Committee)
• Performs train the trainer and Qualified Personnel responsibilities as assigned