ARUP Laboratories
Quality Specialist I, Section Support
ARUP Laboratories, Salt Lake City, Utah, United States, 84193
Quality Specialist I, Section Support
Schedule : Monday - Friday (40 hrs/wk)
Hours : 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.
Essential Functions
Facilitates quality improvement initiatives and 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 department monthly quality meetings.
Prepares minutes from monthly QA meetings for circulation by DCS.
Investigates out‑of‑threshold quality metrics with department staff.
Initiates nonconformances, Report and Learn (RL) events, or MasterControl (MC) deviations as appropriate.
Acts as nonconformance/RL/MC evaluator/responder or reviewer.
Facilitates root cause analysis, CAPAs, evaluates minor nonconformances, RLs, MC deviations, and/or variances for trends.
Facilitates updates and ensures accuracy through 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 and may serve as document collaborator or author.
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 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 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 (IQ/OQ/PQ).
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: 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: Conduct work in compliance with all ARUP Policies and Procedures.
Sedentary Work: Exert up to 10 pounds of force occasionally or negligible 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.
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 : High School Diploma or Equivalent or better.
Preferred : Associate’s Degree or better, Bachelor’s Degree or better.
Experience
Required:
Bachelor’s degree and three (3) years of experience in a high‑complexity clinical laboratory or quality experience in a regulated environment or ARUP work experience in the applicable section.
Or Associate’s degree and five (5) years of experience in a high‑complexity clinical laboratory or quality experience in a regulated environment or ARUP work experience in the applicable section.
Or High School Diploma or equivalent and seven (7) years of experience in a high‑complexity clinical laboratory or quality experience in a regulated environment or ARUP work experience in the applicable section.
Preferred:
Appropriate certification (MLS, MT, 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
Preferred:
Applicable ASCP or AAB, Applicable ASQ.
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Hours : 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.
Essential Functions
Facilitates quality improvement initiatives and 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 department monthly quality meetings.
Prepares minutes from monthly QA meetings for circulation by DCS.
Investigates out‑of‑threshold quality metrics with department staff.
Initiates nonconformances, Report and Learn (RL) events, or MasterControl (MC) deviations as appropriate.
Acts as nonconformance/RL/MC evaluator/responder or reviewer.
Facilitates root cause analysis, CAPAs, evaluates minor nonconformances, RLs, MC deviations, and/or variances for trends.
Facilitates updates and ensures accuracy through 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 and may serve as document collaborator or author.
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 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 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 (IQ/OQ/PQ).
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: 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: Conduct work in compliance with all ARUP Policies and Procedures.
Sedentary Work: Exert up to 10 pounds of force occasionally or negligible 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.
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 : High School Diploma or Equivalent or better.
Preferred : Associate’s Degree or better, Bachelor’s Degree or better.
Experience
Required:
Bachelor’s degree and three (3) years of experience in a high‑complexity clinical laboratory or quality experience in a regulated environment or ARUP work experience in the applicable section.
Or Associate’s degree and five (5) years of experience in a high‑complexity clinical laboratory or quality experience in a regulated environment or ARUP work experience in the applicable section.
Or High School Diploma or equivalent and seven (7) years of experience in a high‑complexity clinical laboratory or quality experience in a regulated environment or ARUP work experience in the applicable section.
Preferred:
Appropriate certification (MLS, MT, 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
Preferred:
Applicable ASCP or AAB, Applicable ASQ.
#J-18808-Ljbffr