Operations Companion Diagnostics Clean Laboratory Supervisor

Organization
Myriad Genetics , Inc.
Job Location
Salt Lake City, UT 84108
Job Description

 

Myriad Genetics is seeking a highly motivated individual to work as a Supervisor in the Companion Diagnostics (CDx) Clean Laboratory to perform robotics operation, formulation and patients’ testing within the FDA’s Quality Systems Regulation (QSR) compliance and CLIA/CAP regulations. The Supervisor will lead a team of technicians to ensure that specified operations are performed as documented by trained CDx lab personnel working in two shifts to produce accurate reporting. The supervisor will also lead the identification and implementation of process improvements as well as troubleshooting and resolution of issues encountered. The supervisor must be qualified to participate in QSR clinical testing, PMA/510(k) studies and audits.

 

Requirements

• Hiring, development and retention of qualified staff members • Planning, including staffing, scheduling and ordering of materials, to ensure the department’s ability to meet the companywide production goals. • Annually evaluating and documenting the performance of all testing personnel • Serve as a trainer on technical processes both within and between groups • Ensuring laboratory compliance with technical, operational, administrative and safety policies • Development and implementation of departmental technical procedures in accordance with the laboratory’s policies and procedures • Ensuring participation of all department personnel in the laboratory’s quality assurance plan, adhering to quality control and preventive maintenance policies and appropriately documenting these activities • Being available to testing personnel at all times during testing and be able to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with the laboratory’s policies and procedures. • Actively participating in successful and timely completion of training and competency assessment as outlined in the laboratory and departmental training programs • Troubleshooting and identifying problems that may adversely affect test performance and/or reporting of test results by initiating corrective action and using the defined electronic system to make the required management notification • Work with Clinical Scientist to lead, support and promote process improvement initiatives and Lean activities • Comply with QSR, CLIA, CAP and applicable state regulations. • Hiring, development and retention of qualified staff members. • Planning, including staffing, scheduling and ordering of materials, to ensure the department’s ability to meet the companywide production goals. • Annually evaluating and documenting the performance of all testing personnel. • Serve as a trainer on technical processes both within and between groups. • Ensuring laboratory compliance with technical, operational, administrative and safety policies. • Development and implementation of departmental technical procedures in accordance with the laboratory’s policies and procedures. • Ensuring participation of all department personnel in the laboratory’s quality assurance plan, adhering to quality control and preventive maintenance policies and appropriately documenting these activities. • Being available to testing personnel at all times during testing and be able to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with the laboratory’s policies and procedures. • Actively participating in successful and timely completion of training and competency assessment as outlined in the laboratory and departmental training programs. • Troubleshoot and identify problems that may adversely affect test performance and/or reporting of test results. Where applicable, initiate CAPAs and use the defined electronic system to make the required management notifications. • Work with Clinical Scientists and others to lead, support and promote process improvement initiatives and Lean activities. • Other responsibilities as assigned. Required Qualifications: • Meets one of the following minimum education requirements: o Doctorate (Ph.D., M.D. or D.O.) in medicine, clinical laboratory science, chemical, physical or biological science with at least 2 years of clinical laboratory experience or, o Master’s in clinical laboratory science, chemical, physical or biological science with at least 3 years of clinical laboratory experience or, o Bachelor’s in a chemical, physical, biological or clinical laboratory/medical technology science, with at least 4 years of clinical laboratory experience. • Experience with molecular genetics testing, specifically with nucleic acid extraction, quantification, and analysis using PCR-based and sequencing methods. • Experience with automation, as well as laboratory and analysis software. • Due to the nature of the tests, extensive documentation and compliance skills are required. • Excellent teamwork and communication skills • Pays attention to detail • Ability to troubleshoot and resolve problems. • Exercises sound judgment • Ability to adapt to change efficiently. Preferred Qualifications: • Previous supervisory experience • Experience in FDA cleared in vitro diagnostic testing and QSR compliance. • Experience with CLIA/CAP testing. • Experience in high throughput screening. Physical and Mental Requirements of the job: Carrying, Communicating, Analyzing, Coordinating, Lifting up to 20lbs, Repetitive Motion, Color Determination

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