Genetron Health is a leading and fast-growing precision oncology company that is committed to providing a one-stop, multi-scenario genomic profiling solutions in areas including early cancer screening, diagnosis and monitoring as well as biopharmaceutical services. It has successfully developed seven NMPA-approved clinical sequencing platforms and gene assays. Partnering over 500 hospitals along with several pharmaceutical companies and research institutions, Genetron Health has built an extensive proprietary genomic database to deliver comprehensive genomic testing services. In China, the company has one R&D center, two manufacturing facilities and five clinical laboratories in Beijing (CLIA-certified and CAP-accredited), Shanghai, Hangzhou, Chongqing and Guangzhou. Its world-class team of scientists has also published many research papers in prestigious scientific journals worldwide.
The company is opening a new R&D center and a CLIA lab in Gaithersburg, Maryland, USA with the following exciting opportunities. Genetron Health Inc offers a family friend work environment, competitive compensation package including paid leave, health/dental insurance, 401(k) with company matching contribution, and annual cash/stock incentive awards. Genetron Health Inc. is an equal employment opportunity employer, and does not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Position Overview:
The CLIA Laboratory Supervisor is in charge of the daily operations of the CLIA laboratory that is expected to provide timely testing as requested and accurate results as required. The Supervisor should always utilize excellent customer service skills for both internal and external customer services. A deep and thorough understanding of testing principles, Quality Control, and teamwork are essential. A positive and professional interpersonal style with a strong commitment to the team effort is mandatory.
Specific Responsibilities:
•Supervises clinical testing and daily operations of the CLIA laboratory consistently according to established standard operating procedures as described in procedure manuals, quality control specifications and workflow guidelines
•Responsible for completion of any special projects, process improvements or new method introduction at the request of the Lab Director
•Ensures that all workflow processes are completed within acceptable time frames. Monitors TAT report to ensure timely reporting of the results
•Responsible for the maintenance and organization of all documentation generated by the laboratory or by instrumentation such as QC, calibrations, etc
•Understands and observes all confidentiality and HIPAA provisions
•Recognizes and conveys to management any departmental improvements necessary
•Responsible for all equipment in assigned areas of work
•Assist and guide technologists with all problems, initiate resolution of errors, document discrepancies, perform troubleshooting on all instruments trained on and resolve all errors and other problems
•Independently perform diagnostic testing with accuracy, precision, and efficiency following established SOPs. Report diagnostic data in compliance with policies, SOPs, and turn-around-time schedules
•Constantly reviewing current procedures and coordinate changes, with director’s approval, in order to implement procedures that will facilitate more accurate and timely reporting of results.
•Ability to perform laboratory calculations.
•Ability to look beyond daily functions to implement higher standards through evaluation and education
•Recognize and resolve all QC discrepancies and assist other technologists, if needed, with resolution of QC discrepancies when necessary
•Perform and document all routine and periodic maintenance according to instrument guidelines and established SOP's.
•Be able to recognize instrument malfunction and independently troubleshoot instrument, assay, and/or analytical problems to prevent delays in patient testing and initiate service calls when necessary
•Communicate all problems, instrument malfunctions, etc. to Lab Director
•Adjusts work assignments to meet the needs of the section/laboratory, when instruments are down, reduced staffing, or areas are slow
•Understand QC concepts, identify problems, and implements corrective action
•Perform all bench, kit, and assay QC. Make sure when QC or kit reagents change that the QA/QC coordinator is notified, and the change is documented
•Perform, monitor, and maintain daily QC, QA, all appropriate maintenance log sheets, discrepancy logs, and maintenance records
•Monitor and document the temperature dependent equipment on Temperature QC log sheets, equipment maintenance log sheets, discrepancy logs, calibration logs, and general work performance logs
•Assumes other duties as assigned by management.