Supervisor, Laboratory CLIA Operations

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. Schedule: Monday - Friday, Possible Saturday The Opportunity The responsibilities of this position are to manage laboratory process to ensure day-to-day operations are in compliance with internal standard operating procedures and the regulatory standards of CLIA, and CAP, manage laboratory personnel by preparing schedules, providing guidance and direction, contribute to the maintenance or development of technical and analytical standards for method evaluation, development of quality improvement initiatives, and evaluation of new instrumentation, analytical methods and laboratory procedures, and to perform additional duties as assigned. What You'll Do The following job duties are delegated to the Supervisor by the Laboratory Director: * Be accessible to testing personnel at all times testing is performed to provide on-site, telephone, or electronic consultation to resolve technical problems in accordance with policies and procedures established by the Laboratory Director or Technical Supervisor. * Provide day-to-day supervision of high complexity test performance by qualified personnel. * Monitor test analyses and specimen examinations to ensure that acceptable levels of analytical performance are maintained. Ensure all remedial action is taken whenever test system deviates from the Laboratory's established performance specifications. Investigate and problem solve laboratory and department incidents, including driving the process forward, review and/or write non-conformance reports, deviations, CAPAs, and incident reports as needed in compliance with QMS system. * Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning. * Provide orientation to all testing personnel. * Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. * Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens, and annually thereafter unless test methodology or instrumentation changes, in which case the individual's performance must be re-evaluated to include the use of the new test methodology or instrumentation. * Performing and documenting competency assessments. Additionally, the Supervisor will also: * Perform highly complex testing according to established standard operating procedures. * Leverage a deep understanding of the process in troubleshooting assays and instrumentation as needed. * Order reagents and consumables. * Track samples progress and respond to sample progress inquiries from Client Services and other departments as needed. * Support all operational aspects of quality assurance and quality control. * Contribute to maintenance of equipment and other technical resources. * Collaborate with internal teams, vendors, and others as needed to resolve issues, maintain ongoing functionality and document service, project management and repair work. * Assist in preparing for, performing and responding to internal and external audits as well as any other inspections. * Represent laboratory operations department at cross functional meetings or to guests as needed. * Demonstrate commitment to maintaining TAT objectives, quality, and continuous improvement. * Review and write standard operating procedures as needed. * Participate on cross functional teams to coordinate trouble shooting, process improvements, and/or implement new workflows or products. * Maintain flexibility to cover scheduling gaps as needed and to be included in the on-call rotation for additional weekend and/or holiday technical support. * Participates in laboratory compliance and quality plans on a regular basis to ensure regulatory obligations are met. * Follows company policies and practices as outlined in all company resources, including, but not limited to, safety and compliance guidelines. * Performs additional duties as assigned. Who You Are & What You Bring Education and Experience: A candidate must: Hold a Bachelor of Science Degree in a chemical, physical or biological science and 4+ years of experience in a molecular clinical laboratory, OR Hold a Bachelor of Science in Medical Technology and 4+ years of experience, OR Hold a Master of Science in Chemical, Physical or Biological Science and subsequent to graduation at least 2 years of molecular clinical laboratory experience. Hold a Doctoral degree from an accredited institution with a chemical, physical or biological science and subsequent to graduation, have had at least two years' experience in molecular laboratory specialties. Certifications or licensure that is required by the state or country in which the job is posted. Minimum of 2 years supervisory experience in a laboratory environment and strong leadership skills to foster a high performing, collaborative team is preferred. Current certification or eligible with ASCP (American Society of Clinical Pathologists) as an MLS - Medical Laboratory Scientist, MT - Medical Technologist, MLT-Medical Laboratory Technician, MB- Molecular Biology or specialist, is preferred. Knowledge, Skills, and Abilities: * Strong experience working in CLIA/CAP compliant lab or another regulated laboratory environment. * Knowledge and experience working with nucleic acid manipulation techniques, enzymatic reactions, and sequencing chemistry. * Experience with ensuring and maintaining integrity and quality of a lab in compliance with QMS. * Experience with a Laboratory Information Management System (LIMS) * Knowledge of accreditation and regulatory standards * Knowledge of laboratory safety protocols * Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.) * Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point. * Demonstrated history working as a leader within a team. * Strong interpersonal skills that include excellent skills in written and verbal communication, collaboration, and problem solving with other departments and colleagues * Excellent organization and attention to detail * Understanding of HIPAA and importance of privacy of patient data * Ability to implement policies and procedures as directed. * Ability to analyze and problem solve complex issues that impact clinical lab performance. * Strong project management abilities * Excellent attention to detail, time management and process management * Ability to monitor key metrics. * Ability to perform a wide variety of tasks and multi-task efficiently to meet deadlines. Who We Are and What We Offer We have an incredibly talented group of down-to-earth professionals with the experience, drive, and creativity to make Bio-Techne a world-class life science solutions company. Our workplace is full of enthusiastic, hardworking, and intelligent people with bold ideas and the determination to see them through. Our best-in-class reagents, instrument, custom manufacturing, and diagnostic tests are used throughout a patient's lifespan by laboratories worldwide. Bio-Techne has locations in Minneapolis, MN, Austin, TX, Boston, MA, Denver, CO and San Jose, CA and all sites offer top-notch technology, educational, and business benefits. Science is our passion; it drives us to collaborate, develop and manufacture award-winning tools that help researchers achieve reproducible and consistent results. Bio-Techne provides a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching, an employee bonus plan, and a tuition reimbursement plan. Additional components of compensation include stock option grants and an annual bonus plan. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. Why Join Bio-Techne: * We offer competitive wages along with extensive benefits for employees and their families. * We invest in our employees' financial futures through retirement programs and an employee stock purchase plan. * We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more. * We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging. * We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an E-Verify Employer in the United States. Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.

Created: 2024-11-02