Clinical Testing Services
Clinical Medical Technologist II/III (CMT II/III)
Overview of the role:
The CMT II/III will competently perform molecular procedures, including nucleic acid isolation, polymerase chain reaction, with a strong and directed emphasis in the performance of Sanger sequencing and Next Generation Sequencing (NGS) test methods. The qualified candidate will process clinical specimens using the appropriate equipment, instruments, or techniques to assure optimum patient specimen integrity and positive identification throughout the test process; perform and evaluate quality control procedures to assure that test execution, test methodologies, and equipment performance are all within the clinical protocol specifications; provide collaborative assistance to colleagues as requested; release findings per laboratory procedures using the Laboratory Information System; complete testing and assigned projects in a timely manner consistent with expected deliverables; assist with implementation of testing protocols; actively participate in development of guidelines, procedures, and operating instructions for assays/instruments as directed; participate in proficiency testing, maintain competency, and execute other projects and duties as assigned.
Essential duties and responsibilities:
- Participate in and provide input into:
– Installation/Operation/Performance Qualifications of new laboratory platforms and instrumentation
– Development of new laboratory technologies and applications
– Defining requirements, specifications, and test cases for implementation of laboratory system software
– Performance of test cases and completion of software life cycle documentation
– Providing support and assistance to QA/QC managers in the recognition, documentation, and resolution of technical issues
– Performance of root-cause analyses, including recommendations for risk mitigation and resolution
- Direct and coordinate training of other laboratory staff
- Recognize and direct regulatory/compliance concerns to the Quality Systems Manager, or Quality Assurance Specialist
- Model compliance with clinical laboratory regulatory policies
- Demonstrate strict adherence to all laboratory processes across all phases of testing
CMT II/III responsibilities per 42 CFR 493.1495: Testing personnel are responsible for specimen processing, test performance, and for reporting test results.
- Each individual performs only those high complexity tests which require a degree of skill commensurate with the individual’s education, training or experience, and technical abilities as authorized by the Laboratory Director.
- Each individual performing high complexity testing must:
– Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results;
– Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;
– Adhere to the laboratory’s quality control policies;
– Document all quality control activities, including instrument and procedural calibrations and maintenance performed;
– Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance;
– Be capable of identifying problems that may adversely affect test performance or reporting of test results;
– Demonstrate knowledge and capacity to recognize and correct problems with appropriate notification to the general supervisor, technical supervisor, clinical consultant, or Laboratory Director;
– Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.
Work Experience, Education, and Computer Skills:
- 6 years experience in a high-complexity laboratory performing molecular testing or 2 years’ experience in a high-complexity laboratory performing molecular testing plus a Masters Degree in Biology, Medical Technology or Molecular Biology, or a related biological science
- Bachelors (BA/BS) or Masters (MA/MS) degree in a relevant scientific discipline.
- Experience in a licensed, high-complexity molecular biology laboratory performing Sanger sequencing testing and analysis is required. Experience performing NGS using the Ion Torrent PGM system is preferred. Association of Clinical Pathology (ASCP) certification preferred. Must meet personnel qualification standards according to Clinical Laboratory Improvement Act, 1988 (CLIA-88) as outlined in 42 CFR 493.1489.
- Job requires specialized computer skills. Must be adept at using various applications including database, spreadsheet, report writing, project management, graphics, word processing, presentation creation/editing, communication by email and use of scheduling software.
- Computer proficiency: Advanced skills in Word, and intermediate skills in Excel and Outlook
Tuesday-Saturday or Monday-Friday
If you are interested in joining our team and would like to be considered for a future job opening, please email your resume to: email@example.com