Quality Specialist I, Testing Support

Quality Assurance Specialist

Schedule: Monday - Friday (40 hrs/wk) Roughly 8 hrs/day to encompass the hours of 9:00 AM - 3:00 PM

Training Schedule: Monday - Friday Roughly 7:30 AM - 4:00 PM, picking up tasks gradually as training progresses for roughly six weeks

Department: Quality Systems & Support - 252 Position will support molecular based area.

Primary 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.
• Captures priorities in annual Quality Specialist fiscal year plan
• Functions as trainer/facilitator for process improvements
• Prepares annual QA/I plan
• Coordinates with Technical Operations leadership on support and prioritization of quality initiatives
• Trends/interprets data and facilitates QA discussion within laboratories' monthly quality meetings
• Prepares minutes from monthly QA meetings for circulation by DCS
• Together with department staff, investigates out of threshold quality metrics
• Initiates 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 Analysis
• Facilitates CAPAs
• Evaluates minor nonconformances, RLs, MC deviations, and/or variances for trends
• Facilitates the updates and ensure accuracy through the annual review of the Quality Task Matrix, Medical Director Criteria Form and other quality documents
• Initiates/oversees the mislabel/suboptimal/pending challenge where applicable
• Provides suggestions for quality-related procedure updates. May serve as a document collaborator or author where appropriate
• Presents quality-related education to area staff meetings
• Prepares/presents client quality issues for weekly/monthly review meetings for ARUP leadership
• Provides Quality training to new supervisors as part of ARUP's new leader training
• Gathers lab specific data for Quality Steering Committee decision making
• Is involved in Pathology Review and Consensus (PaRC), where appropriate for areas of support
• Develops/coordinates mock inspections within areas of support, as appropriate
• Performs audits as part of the internal audit program
• Supports the proficiency testing programs and activities for labs; completion, coverage, records. May participate in PT Annual Ordering event
• Initiates PT Problem Reports - review, approval and follow up
• Supports labs during assessments/inspections/surveys from CAP, NY, FDA, AABB, California, ISO 15189, and other regulatory agencies
• Acts as a liaison as needed to assist with responses to accreditation deficiencies and/or gaps
• Reviews instrument correlation studies, where appropriate
• Develops instrument validation and re-validation/verification plans for instruments and equipment, as appropriate
• Evaluates and maintains corporate equipment verification plans and corresponding procedures
• Reviews/approves instrument/equipment validations (IQ/OQ/PQ)
• May review QC Summary report for completion, if applicable
• Other duties as assigned

Physical 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.

Qualifications:

Education Required + Bachelor's Degree or better in Medical Laboratory Sciences

Licenses & Certifications Preferred + Applicable ASQ

Experience Required + 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 environment

Preferred + Combination of high complexity clinical laboratory experience and quality experience in a regulated environment + ASCP certification in area of support (MLS or Molecular Biology) + Quality-focused certification such as ASQ belt + Master's degree

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities