Each employee’s specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows:
* 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 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.
* Serve as a trainer on technical processes within the group.
* Assist in achieving and maintaining laboratory certifications as appropriate.
* Ph.D. in life science with at least 1 year of molecular diagnostic laboratory experience; or
* Master’s degree in clinical laboratory or life science with at least 3 years of clinical laboratory work experience; or
* Bachelor’s degree in clinical laboratory or life science with at least 5 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 requiredRequires good attention to detail
* Good verbal and written communication skills
* Requires the ability to adapt to change efficiently
* 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