Quality Specialist I, Section Support

Arup Laboratories • Salt Lake City, UT

69d

About The Position

The position provides services of a quality nature and participates in the development of Quality Assurance/Improvement (QA/I) plans for associated technical areas. The role oversees and coordinates quality assurance activities for the group(s) and supports the associated laboratory's nonconformance investigations (root cause analyses) and corrective and preventive actions (CAPAs). The individual evaluates and ensures that problem solving and corrective actions are thorough, timely, complete, accurate, and effective. They facilitate the proficiency testing and indicator processes within the areas of support, evaluate compliance with all associated policies, procedures, and regulations, and communicate status to laboratory management and Quality Systems & Support management. The position also leads quality-focused process improvement activities.

Requirements

• Experience in quality assurance or quality improvement in a laboratory setting.
• Knowledge of regulatory requirements and quality standards in laboratory operations.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in a team environment.

Nice To Haves

• Experience with root cause analysis and corrective action processes.
• Familiarity with proficiency testing and laboratory accreditation processes.
• Previous experience in training or facilitating quality improvement initiatives.

Responsibilities

• Facilitates quality improvement initiatives and captures priorities in the 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 together with department staff.
• Initiates nonconformances, Report and Learn (RL) events, or MasterControl (MC) deviations as appropriate.
• Functions as nonconformance/RL/MC deviation evaluator/responder or reviewer.
• Facilitates Root Cause Analysis and CAPAs.
• Evaluates minor nonconformances, RLs, MC deviations, and/or variances for trends.
• Facilitates updates and ensures 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 and may serve as a 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.
• 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.
• 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 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).
• Performs other duties as assigned.

Benefits

• Diversity and professional growth opportunities.
• Continuous development programs.

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 1,001-5,000 employees