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Job Information

ARUP Laboratories Quality Coordinator II in Salt Lake City, Utah

Description

Schedule:Monday - Friday (40 hrs/wk)8:30 AM - 5:00 PM

Department: Quality Systems & Support - 252

Primary Purpose:

Assesses compliance to new and existing regulations from all regulatory, certifying, licensing, and accrediting agencies. Supports nonconformance investigation and corrective action processes. Assists in the formulation and execution of new corporate policies, processes, and procedures. Supports regulatory and quality training for ARUP employees, as needed. Assists departments with regulatory and quality needs. Provides corporate quality support for nonconformance investigation and corrective actions. 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. 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: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc. Communicate: Frequently and effectively 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: To conduct self in compliance with all ARUP Policies and Procedures. Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling. Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.

Qualifications

Education

Required

  • Bachelor's Degree or better in Biological Sciences

Licenses & Certifications

Preferred

  • Applicable ASCP or AAB

  • Applicable ASQ

Experience

Required

  • Three years of work experience in a high complexity clinical laboratory and/or quality/regulatory experience in a regulated environment. Two of the overall three years must be quality focused. Clinical Trials: Three years experience must be in an FDA regulated laboratory environment

  • Working knowledge of regulatory requirements applicable to clinical laboratories

  • Demonstrated knowledge of ISO, CLIA, CAP and/or FDA

Preferred

  • Regulatory/quality experience with clinical trials (medical devices and/or pharmaceuticals)

  • Strong understanding of good clinical practice guidelines (GCP)

  • Five years of work experience in quality, regulatory and/or compliance

  • Advanced knowledge and experience with ISO, CLIA, CAP, NY, FDA, and/or DNV requirements

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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