Caris Life Sciences
Location
Phoenix, Arizona
The Molecular Training Specialist performs a variety of molecular techniques including NGS and PCR while ensuring data quality and regulatory compliance. They are also responsible for managing employee training, competency samples, and contributing to process improvement initiatives.
Requires a Bachelor's or Master's degree in a biological or clinical science with at least 4 years of clinical lab experience, including 1 year in high-complexity molecular testing. Proficiency in molecular workflows, assay troubleshooting, and quality control methodologies is essential.
Molecular Training Specialist is responsible for performing a broad range of molecular techniques that include, but are not limited to, blood processing and buffy coat extraction, RNA/DNA extractions, PCR, Next-Generation Sequencing, equipment maintenance, laboratory inventory, sample tracking and receiving packages. The Molecular Training Specialist works independently with minimal supervision and provides technical expertise in assigned workflows, ensures data quality, and contributes to process improvement and training initiatives. This position works under the direction of the supervisor and follows standard laboratory procedures and policies. Job Responsibilities Maintain regulatory compliance to all applicable regulatory requirements (FDA, CLIA, NYS, ISO, CAP, etc.) Maintains exceptional quality standards for all molecular analysis. Initiates, tracks and documents the creation of competency samples. Initiates, tracks and documents the progress of employee training, including the review of cap checklists. Completes data analysis and concordance for competencies and training samples. Assists in high complexity projects and process improvements. Supports validation efforts and new assay implementation by acquiring proficiency in new assays and creating and delivering training to molecular technologists. Initiates, tracks and documents continuing education hours. Meets all deliverables and goals set by department. Adheres to the laboratory’s quality control policies, documents all quality control activities, instrument and procedural calibrations and maintenance performed. Documents all corrective action taken when a test system deviates from the laboratory’s established performance specifications. Assists with the tracking, accumulation, and computation of performance metrics to include turnaround times, issue reviews and case tracking. Documents and reviews all accreditation agency pre-inspection paperwork and mandatory checklists. Performs periodic audits within the Molecular Department to ensure we maintain compliance. Participate in Quality Control / Quality Assurance process improvements. Capture, trend and analyze quality data monthly. Drive identified actions. Provide departmental and companywide training on regulatory requirements and quality control processes. Accepts other duties as assigned. Required Qualifications Bachelor's or Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution. 4+ years clinical lab experience with at least 1 year being high complexity molecular testing Demonstrated proficiency in molecular workflows and assay troubleshooting. High technical accuracy and efficiency across multiple assays. Good knowledge of quality control and monitoring methodologies. Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, general working knowledge of Internet for business use, and skilled in operating office equipment such as fax machines and copiers.
Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution. Experience in FDA regulated industries. Knowledge of laboratory safety procedures for biohazards and chemicals, as well as quality control procedures and regulations Ability to work in a fast-paced, deadline driven environment. Drive for Results (Service, Quality, and Continuous Improvement) – ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement. Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team. Physical Demands Will work at a computer some of the time as well as need to keep inventory and ordering records requiring the use of copiers, fax machines, and PDF scanners. Visual acuity and analytical skill to distinguish fine detail. Ability to pass a visual color discrimination test. Manual dexterity to use common laboratory equipment and perform sterile techniques as required. Must possess ability to sit and/or stand for long periods of time. Must possess ability to perform repetitive motion. Ability to lift up to 30 pounds. May have exposure to high noise levels, fumes, and bio-hazardous material in the lab environment. Exposure to formaldehyde, xylene, Clorox Bleach, DAB and alcohol which emit fumes. The formaldehyde, xylene, and DAB are carcinogenic. May be required to handle blood-borne pathogens and general laboratory reagents. May have exposure to extreme temperatures, high noise levels, fumes, and bio-hazardous material/chemicals including formalin in the lab environment. Required Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.
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