Quality Coordinator III

ARUP Laboratories; Salt Lake City (UT); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading clinical and anatomic pathology reference lab is seeking a Quality Coordinator III. This role involves ensuring compliance with regulatory requirements and leading quality improvement projects. The ideal candidate will have extensive experience in quality assurance and regulatory standards, alongside strong data analysis skills. Join a team dedicated to high-quality laboratory services in a dynamic environment.

Qualifications

• Six years of lab and/or quality/regulatory experience, with four years focused on quality.
• Proficiency in Microsoft Office and data analysis tools.

Responsibilities

• Maintain knowledge of applicable regulations (ISO, CLIA, CAP, FDA, GCP).
• Lead projects for the Quality Steering Committee and support audit activities.
• Investigate nonconformances and facilitate CAPAs.

Skills

Data Analysis

Regulatory Knowledge

Communication

Education

Bachelor's in Biological Sciences

Master's in related fields

Tools

Microsoft Office

Data Analysis Tools

Job description

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Schedule:

Monday - Friday (40 hrs/wk)
8:00 AM - 4:30 PM

Department:

Quality Systems & Support - 252

Primary Purpose:

Assesses compliance to regulatory, certifying, licensing, and accrediting agencies' requirements. Serves as SME for quality programs supporting the QMS, including nonconformance, CAPA systems, investigations, and supplier qualification. Leads policy development, continuous improvement activities, and regulatory training. Supports daily workflow of staff in the QC area.

About ARUP:

ARUP Laboratories is a national clinical and anatomic pathology reference lab, part of the University of Utah, based in Salt Lake City, Utah. We value diversity, professional growth, and excellence, serving over one million patients monthly. Our mission is to provide high-quality laboratory services with a patient-centered approach.

Essential Functions:

• Maintain knowledge of applicable regulations (ISO, CLIA, CAP, FDA, GCP).
• Develop and review processes for compliance, including policies, audits, and document control.
• Lead projects for the Quality Steering Committee and support audit activities.
• Investigate nonconformances and facilitate CAPAs.
• Support and guide other QC staff.
• Use data analysis to identify trends and lead improvement projects.
• Write and update procedures.
• Respond to quality requests and serve as SME in nonconformance/CAPA processes.

Physical and Other Requirements:

Includes bending, reaching, mobility, communication, PPE use, and visual acuity, in a biohazard environment.

Qualifications:

Required:

• Bachelor's in Biological Sciences or related field.
• Six years of lab and/or quality/regulatory experience, with four years focused on quality.
• Proficiency in Microsoft Office and data analysis tools.
• Knowledge of regulatory requirements (ISO, CLIA, CAP, NY, FDA).

Preferred:

• Master's in related fields.
• Certifications like MT, MLS, ASCP, or ASQ.
• Experience at ARUP and in GMP/GCP environments.

Seniority level:

Mid-Senior level

Employment type:

Full-time

Job function:

Quality Assurance

Industries:

Hospitals and Health Care