Ensures compliance to new and existing regulations from all regulatory, certifying, licensing, and accrediting agencies. Assists in the development of internal audit tools and performs internal audits. Participates in mock inspections. 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.
Clinical trials: Provides corporate quality support for ARUP's PharmaDx and Clinical Trials programs for testing that is conducted for pharmaceutical and medical device investigations.
Gains and maintains advanced knowledge of current requirements of federal, state, local governments and other accrediting and licensure bodies, specifically in regards to ARUP's PharmaDx/Clinical Trial's programs (e.g. ISO, CLIA, CAP, FDA). Assists in the development of and provides regulatory/quality guidance/resources and training to all ARUP departments, as required.
Develops/maintains competency for assigned back-up quality coordinator that also supports the PharmaDx and Clinical Trials departments as assigned. Acts as back-up to other Quality Coordinators as needed.
Bachelor's Degree or better in Biological Sciences or related field.
3 years: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.
3 years:Clinical Trials: 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
Regulatory/quality experience with clinical trials (medical devices and/or pharmaceuticals)
Strong understanding of good clinical practice guidelines (GCP)
5 years:Work experience in quality, regulatory and/or compliance
1 year:ARUP in the Quality Systems & Support department
Advanced knowledge and experience with ISO, CLIA, CAP, NY, FDA, and/or DNV requirements
Licenses & Certifications
Applicable ASCP or AAB
Internal Number: QUALI06593
About ARUP Laboratories
ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and a worldwide leader in innovative laboratory research and development. A nonprofit enterprise of the University of Utah, ARUP offers an extensive test menu of highly complex and unique medical tests.An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.