Quality Specialist , Section Support

Location
: ARUP Main, 500 Chipeta Way, Salt Lake City, UT , USA

Schedule :
Monday - Friday (40 hrs/wk) 8:00 AM - 5:00 PM

Department :
Quality Systems & Support - 252

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 ensures 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.

• Facilitates quality improvement initiatives. Capture 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 department monthly quality meetings
• Prepares minutes from monthly QA meetings for circulation by DCS
• Together with department staff, investigates out of threshold quality metrics
• Initiates nonconformances, Report and Learn (RL) events, or Master Control (MC) deviations as appropriate (may require technical operations’ assistance)
• Functions as nonconformance/RL/MC deviation – evaluator/responder OR reviewer (at least one)
• 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, MD 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
• As applicable, supports the proficiency testing programs and activities; completion, coverage, records. May participate in PT Annual Ordering event
• Initiates PT Problem Reports, if needed - review, approval and follow up
• Supports labs during assessments/inspections/surveys from CAP, NY, FDA, AABB, California, ISO 15189, and other regulatory agencies
• Serves as a liaison as needed to assist with responses to accreditation deficiencies and/or gaps
• Evaluates and maintains corporate equipment verification plans and corresponding procedures
• Reviews/approves instrument/equipment validations…