Supervisor, Clinical Laboratory
MedTechPharmaBiotechRegulatory AffairsQuality Assuranceheoremaraveinformaws
Job description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works in Redwood City, CA supporting our clinical laboratory teams in the Cancer Diagnostics division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions. Position Overview The Supervisor, Clinical Laboratory directs the day-to-day laboratory operations, under the direction of the Director of Laboratory Operations (or designee); including, but not limited to, the general supervision and development of laboratory staff, assuring quality standards are met, providing technical expertise to the laboratory, and serving as the liaison to various internal and external entities, as needed. The Supervisor, Clinical Laboratory oversees the quality management program in the laboratory and ensures that the laboratory and laboratory staff follow all laws and regulations that are required by CLIA, CAP, OSHA, and any other applicable legislative organizations. This role meets the CAP requirements for General Supervisor. Shift: Monday – Friday 7:00am – 3:30pm Essential Duties: Include, but are not limited to, the following: Identify and understand regulatory requirements to ensure the laboratory is compliant with all applicable laws and regulations pertinent to the management of the laboratory, including applicable CLIA, CAP and other requirements and regulations. In conjunction with support staff, maintain a process for staffing, recruiting, training, evaluation of competency, and ongoing educational development. Provide supervision to the laboratory and is accessible to the laboratory personnel to provide on-site consultation. Evaluate equipment and supply needs of the laboratory. Work with laboratory leadership to ensure expenses are within the departmental budget. Assure proper ordering of supplies and equipment. Monitor supply usage and variances. Review test volumes with the laboratory leadership to ensure appropriate staffing to maintain established turn-around-times. Verify the test procedures performed, and along with laboratory leadership establish the laboratory’s test performance characteristics; including precision and accuracy of each test and test system. Ensure that the Quality Management program is maintained by following parameters for acceptable performance for the pre-analytical, analytical, and post-analytical testing processes. Resolve all technical problems, with the aid of the technical staff, and ensure that remedial action is taken whenever a test deviates from the laboratory’s performance standards. Ensure that all patient results are not reported until corrective actions have been taken and the systems are functioning properly. Identify training needs and ensure all training is performed as required. Evaluate competency of all laboratory personnel. Possess effective management abilities to supervise department staff and maintain budgets. Verify the test procedures performed. This is accomplished by: Reviewing proficiency testing. Reviewing corrected reports and incident reports. Reviewing Quality Control at least monthly. Ensure that the Quality Control program is maintained by following parameters for acceptable limits and levels are maintained throughout the entire testing process from initial receipt of specimen to reporting results. Sign technical training records. Design training checklists. Evaluate competency of all testing personnel with the help of technical staff and ensure that the staff maintains their competency to perform test procedures and report test results promptly, accurately, and proficiently. Directly observing routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing. Monitor the recording and reporting of results. Review intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance. Assess test performance through testing previously analyzed specimens (QA Split Samples, contrived specimens) or external proficiency testing samples. Assess problem solving skills. Evaluate and document the performance and competency of individuals six months after initial employment. Thereafter, evaluations must be done annually unless method or instrumentation changes; in which case, before reporting patient results, the individual’s performance must be reevaluated. Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain
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