The CLIA Lab Medical Technologist should have at least five years of experience in a CLIA/CAP/FDA regulated environment and direct experience with high-complexity testing. The ideal candidate will have experience in NGS-based molecular diagnostic test methods and have prior experience in execution and reporting of clinical diagnostic testing. This position will report to the CLIA Lab Manager and will be responsible for carrying out clinical testing activities. This is an onsite position that’s based in Natick, MA.
Duties and responsibilities
• Responsible for performing a variety of routine and highly specialized diagnostic tests, procedures and accompanying documentation.
• Proficient in manual testing techniques with a high level of accuracy and precision.
• Perform and understand quality control programs including evaluation of values, documentation of errors and corrective action, and the maintenance of records in the appropriate logs.
• Ability to work through all phases of laboratory testing including pre-analytical, analytical and post-analytical.
• Independently perform sample accessioning, DNA/RNA extractions, PCR and NGS runs, analyze data, and prepare technical reports according to standard operating procedure.
• Organize samples/specimens, maintain inventory, prepare buffers and reagents, and update specimen database as needed.
• Identify, report, and troubleshoot procedural deviations and out of specification results.
• Perform and record scheduled equipment maintenance, troubleshooting of equipment problems, and providing immediate notification to supervisor in the event of any malfunctions.
• Participate in approved proficiency programs, assign testing activities, and ensure timely reporting as needed.
• Participate in clinical laboratory quality assurance programs.
• Contribute to, review, edit and write SOP and any Quality Management system documentation as needed.
• Respond with appropriate investigation and corrective / preventive actions as needed.
• Participate in routine laboratory tasks and provide support to other laboratory staff as needed.
• Perform activities for CLIA inspection-readiness as needed.
• Ensure compliance with safety programs and procedures including blood borne pathogens, chemical hygiene and biohazardous material.
• Participate in continuing education activities.
Minimum Education and Experience Requirements
Education: B.S. in Biology, Molecular Biology, Genetics or related field
Experience:
• 5 years of experience in a CLIA/CAP/FDA regulated environment.
• 2 year of hands-on experience in preparing NGS libraries, running NGS instruments and processing NGS data.
• Experience with LIMS, analytical analysis, test system validations and troubleshooting is preferred.
• Direct experience with CLIA inspections is preferred.
• ASCP certification is preferred
Knowledge, Skills, and Abilities:
• Excellent molecular biology skills are required.
• Exceptional record keeping is required.
• Work in a structured and regulated environment.
• Work productively in group situations as well as independently.
This position is conducted in a standard lab environment. Must be able to perform work while sitting or standing for long periods of time. Position may at times require repetitive movements. Must be able to lift, push, pull and carry up to 25 lbs.
