Quality Specialist I, Testing Support - Molecular Division

Quality Assurance SpecialistSchedule: Monday - Friday (40 hrs/wk) 8:00 AM - 4:30 PMTraining Schedule: Monday - Friday (40 hrs/wk) 7:30 AM - 4:00 PMDepartment: Quality Systems & Support - 252Primary Purpose: Provides services of a quality nature. Participates in the development of Quality Assurance/Improvement (QA/I) plans for associated technical areas. Oversees and coordinates quality assurance activities for the group(s). Supports the associated laboratory's nonconformance investigations (root cause analyses) and corrective and preventive actions (CAPAs). Evaluates and supports that problem solving and corrective actions are thorough, timely, complete, accurate, and effective. Facilitates the proficiency testing and indicator processes within the areas of support. Evaluates compliance with all associated policies, procedures, and regulations and communicates status to laboratory management and Quality Systems & Support management. Leads quality-focused process improvement activities.About ARUP: ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient's life. We never forget that there is a patient behind every specimen we receive.We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.Essential Functions:Facilitates quality improvement initiatives. Capture priorities in annual Quality Specialist fiscal year planFunctions as trainer/facilitator for process improvementsPrepares annual QA/I planCoordinates with Technical Operations leadership on support and prioritization of quality initiativesTrends/interprets data and facilitates QA discussion within laboratories' monthly quality meetingsPrepares minutes from monthly QA meetings for circulation by DCSTogether with department staff, investigates out of threshold quality metricsInitiates non-conformances, Report and Learn (RL) events, or MasterControl (MC) deviations as appropriate (may require technical operations' assistance for support departments with high volumes of non-conformances)Functions as nonconformance/RL/MC deviation – evaluator/responder OR reviewer (at least one)Facilitates Root Cause AnalysisFacilitates CAPAsEvaluates minor nonconformances, RLs, MC deviations, and/or variances for trendsFacilitates the updates and ensure accuracy through the annual review of the Quality Task Matrix, Medical Director Criteria Form and other quality documentsInitiates/oversees the mislabel/suboptimal/pending challenge where applicableProvides suggestions for quality-related procedure updates. May serve as a document collaborator or author where appropriatePresents quality-related education to area staff meetingsPrepares/presents client quality issues for weekly/monthly review meetings for ARUP leadershipProvides Quality training to new supervisors as part of ARUP's new leader trainingGathers lab specific data for Quality Steering Committee decision makingIs involved in Pathology Review and Consensus (PaRC), where appropriate for areas of supportDevelops/coordinates mock inspections within areas of support, as appropriatePerforms audits as part of the internal audit programSupports the proficiency testing programs and activities for labs; completion, coverage, records. May participate in PT Annual Ordering eventInitiates PT Problem Reports - review, approval and follow upSupports labs during assessments/inspections/surveys from CAP, NY, FDA, AABB, California, ISO 15189, and other regulatory agenciesActs as a liaison as needed to assist with responses to accreditation deficiencies and/or gapsReviews instrument correlation studies, where appropriateDevelops instrument validation and re-validation/verification plans for instruments and equipment, as appropriateEvaluates and maintains corporate equipment verification plans and corresponding proceduresReviews/approves instrument/equipment validations (IQ/OQ/PQ)May review QC Summary report for completion, if applicableOther duties as assignedPhysical and Other Requirements:Stooping: Bending body downward and forward by bending spine at the waist.Reaching: Extending hand(s) and arm(s) in any direction.Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.Communicate: Frequently communicate with others.PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as making general observations of depth and distance.QualificationsEducation: Bachelor's Degree or better in Medical Laboratory Sciences or related field.Experience: Bachelor's degree in Clinical or Medical Laboratory Science, Medical Technology or in the chemical or biological sciences and three years high complexity testing experience in a clinical laboratory or quality experience in a regulated environmentPreferred: Appropriate certification i.e. MLS (ASCP), MT (ASCP), or categorical applicable to the area(s) of responsibility Quality specialty certification, preferably from ASQ (e.g., six sigma belt, certified quality auditor, certified quality process analyst, etc.)Licenses & Certifications: Applicable ASCP or AAB Applicable ASQ Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. 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