Companion Diagnostics Laboratory Technician II / III | GenomeWeb

Companion Diagnostics Laboratory Technician II / III

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

 

The Companion Diagnostics (CDx) Laboratory Technician II or III is responsible for specimen processing, nucleic acid purification, testing and monitoring test performance within a Quality Systems Regulation (QSR) compliant laboratory. The technician must demonstrate competency, as defined in the department’s training program, prior to performing independent testing. This position will work with department management and quality team members to ensure that laboratory activities are defined, documented and completed to support inspection readiness and that compliance is maintained through procedures, training, documentation and continuous improvement projects. The technician must be qualified to participate in FDA studies and audits.

 

This position is in the swing shift (Monday-Friday, ~ 4 pm to 12:30 am) of the CDx Clean and/or Main Labs.

 

 

Requirements

Each employee’s specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows: • Complying with the laboratory’s technical, administrative and safety policies and procedures. • Comply with the laboratory’s technical, administrative and safety policies and procedures. • Participate in the laboratory’s quality assurance plan, adhering to quality control and preventive maintenance policies and appropriately documenting these activities. • Comply with QSR, CLIA, CAP and applicable state regulations.Follow the laboratory’s policies and procedures whenever test systems are not within acceptable limits and documenting the problem and any corrective action. • Troubleshoot and identify problems that may adversely affect test performance and/or the reporting of test results by initiating corrective action and using the defined electronic system to make the required management notification. • Perform proficiency testing in the same manner as routine samples. • Actively participate in the successful and timely completion of training and competency assessment as outlined in the laboratory and departmental training programs. • Where competency has not been approved by supervision, will work under the direct supervision of an employee competent on the task. • Participate in continuing education according to accepted laboratory standards. • Participate in departmental and cross-functional teams to resolve problems or implement projects. • Assist in achieving and maintaining laboratory certifications as appropriate. • May serve as a trainer on technical processes within the group. Required Qualifications: • Master’s degree in clinical laboratory or life science with at least 1 year of clinical laboratory work experience; or • Bachelor’s degree in clinical laboratory or life science with at least 2-3 years of clinical laboratory work experience. • Experience with molecular genetics testing, specifically with nucleic acid extraction, quantification, and analysis using PCR based 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 • Requires good attention to detail • Good verbal and written communication skills • Requires the ability to adapt to change efficiently Preferred Qualifications: • Experience with CLIA/CAP and/or FDA cleared in vitro diagnostic tests • Experience in a QSR/cGMP system • Expertise in qualitative and quantitative PCR, Sanger sequencing, Next Generation Sequencing, microarrays, and high throughput screening. Physical and Mental Requirements of the job: Lifting up to 20lbs, Pulling and/or Pushing, Carrying, Repetitive Motion, Near Acuity, Color Determination, Depth Perception

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Tanya Sandrock

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