Job Information
ARUP Laboratories Quality Coordinator I in Salt Lake City, Utah
Description
Schedule :Monday - Friday (40 hrs/wk)8:00 AM - 4:30 PM
Department: Quality Systems & Support - 252
Primary Purpose :
Assesses compliance to new and existing regulations from applicable regulatory, certifying, licensing, and accrediting agencies and makes recommendations based on those assessments. Assists in the quality corporate programs’ support of the Quality Management System (QMS) including, but not limited to: the nonconformance and CAPA systems, associated investigational activities and supplier qualification activities. Assists in the formulation and execution of new corporate policies, processes, and procedures. May facilitate corporate continuous improvement activities. Supports regulatory and quality training for ARUP employees, as needed. Assists departments with regulatory and quality needs.
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.
Essential Functions :
Gains and maintains knowledge of current requirements of federal, state, local governments and other accrediting and licensure bodies, specifically regarding ARUP Corporate implementation and compliance to those regulations affecting global quality and compliance processes (e.g. ISO, CLIA, CAP, FDA, GCP). Provides quality resources to all ARUP departments, as required.
Develops/reviews processes to ensure ARUP’s compliance with new and existing corporate regulatory compliance requirements. Such processes may include assisting in the development/review of written policies and procedures, internal and external audits, and document control.
Develops/maintains standardized policies, processes, and procedures. Initiates and facilitates the adoption of these processes throughout all ARUP departments.
Accepts assignments and supports projects directed by the Quality Steering Committee (QSC); supports presentations to QSC for process improvements.
Supports internal QMS audits in conjunction with other Quality Coordinators and Quality and Regulatory Affairs Specialists. Performs audits, mock inspections, and surveys as assigned. Prepares written and verbal reviews of all audits. Supports inspection readiness activities and tool development.
Acts as back up to other Quality Coordinators, as needed.
Utilizes data analysis tools to assess and identify trends.
Writes and maintains current procedures as required for areas of responsibility.
Provides timely response to all ARUP departmental quality requests and issues within scope of responsibility
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: 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 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.
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
Experience
Required
- Three years of work experience in a high complexity clinical laboratory and/or quality/regulatory experience in a regulated environment
Preferred
Experience presenting to large audiences
Detailed oriented and excellent written and verbal communication skills
Experience with Microsoft Office Suite
Four years of work experience in quality, regulatory, and/or compliance in a regulated environment with progressively increasing responsibilities
Experience at ARUP in a technical section
Knowledge and experience with ISO, CLIA, CAP, DNV, or FDA requirements
GMP or GCP knowledge
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)