Quality Assurance Coordinator I

2 weeks ago


Salt Lake, Utah, United States ARUP Laboratories Full time

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

Department: Quality Systems & Support - 252

Primary Purpose:

The Quality Assurance Coordinator I plays a crucial role in evaluating adherence to both new and established regulations from relevant regulatory, certifying, licensing, and accrediting bodies. This position provides insightful recommendations based on these evaluations. The coordinator supports the corporate quality programs related to the Quality Management System (QMS), including, but not limited to, the nonconformance and Corrective and Preventive Action (CAPA) systems, investigational activities, and supplier qualification processes. Additionally, the role involves assisting in the development and implementation of new corporate policies, processes, and procedures, while also facilitating continuous improvement initiatives.

About ARUP:

ARUP Laboratories serves as a national reference laboratory specializing in clinical and anatomic pathology, operating as part of the University of Utah and its Department of Pathology. Located in Salt Lake City, Utah, ARUP is dedicated to hiring exceptional talent to foster a diverse work environment that emphasizes professional growth and ongoing development. Our workforce is committed to delivering vital services to over one million patients each month, striving for excellence and engaging with advancements in medicine and the integral role laboratory services play in patient care.

We seek individuals who wish to contribute to ARUP's culture of accountability, integrity, service, and excellence. Join our dynamic team.

Essential Functions:

The Quality Assurance Coordinator I is responsible for:

  • Maintaining up-to-date knowledge of federal, state, and local regulations, as well as standards from accrediting and licensure bodies that impact global quality and compliance processes (e.g., ISO, CLIA, CAP, FDA, GCP).
  • Providing quality resources to all ARUP departments as needed.
  • Developing and reviewing processes to ensure compliance with corporate regulatory requirements, including assisting in the creation and review of written policies and procedures, conducting internal and external audits, and managing document control.
  • Establishing and maintaining standardized policies, processes, and procedures, and promoting their adoption across all ARUP departments.
  • Accepting assignments and supporting projects directed by the Quality Steering Committee (QSC), including preparing presentations for process improvements.
  • Assisting in internal QMS audits alongside other Quality Coordinators and Quality and Regulatory Affairs Specialists, conducting audits, mock inspections, and surveys as assigned, and preparing comprehensive reports.
  • Acting as a backup for other Quality Coordinators as necessary.
  • Utilizing data analysis tools to assess and identify trends.
  • Documenting and maintaining current procedures relevant to the areas of responsibility.
  • Responding promptly to all departmental quality requests and issues within the scope of responsibility.
  • Performing other duties as assigned.

Physical and Other Requirements:

The role requires:

  • Stooping: Bending the body downward and forward.
  • Reaching: Extending hands and arms in any direction.
  • Mobility: Occasionally moving between work sites and within the office.
  • Communication: Frequently and effectively communicating with others.
  • PPE: Working in a biohazard laboratory environment necessitating personal protective equipment in accordance with regulations and company policies.
  • Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible force frequently.
  • Fine Motor Control: Engaging in tasks requiring precise finger movements.
  • Vision: Having close, far, and peripheral visual acuity for various tasks.

Qualifications:

Education:

Required: Bachelor's Degree or higher in Biological Sciences.

Experience:

Required: Three years of experience in a high-complexity clinical laboratory or quality/regulatory experience in a regulated environment.

Preferred:

  • Experience presenting to large audiences.
  • Detail-oriented with excellent written and verbal communication skills.
  • Proficiency in Microsoft Office Suite.
  • Four years of progressively responsible experience in quality, regulatory, and/or compliance in a regulated environment.
  • Experience at ARUP in a technical section.
  • Knowledge of ISO, CLIA, CAP, DNV, or FDA requirements.
  • Familiarity with GMP or GCP standards.

Equal Opportunity Employer: ARUP Laboratories is an equal opportunity employer, committed to creating a diverse environment. We encourage applications from all qualified individuals, including protected veterans and individuals with disabilities.



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