Job Description

UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system based in Orange County. UCI Health is comprised of its main campus, UCI Medical Center , a 459-bed, acute care hospital in in Orange, Calif., four hospitals and affiliated physicians of the UCI Health Community Network in Orange and Los Angeles counties and ambulatory care centers across the region. Listed among America’s Best Hospitals by U.S. News & World Report for 23 consecutive years, UCI Medical Center provides tertiary and quaternary care and is home to Orange County’s only National Cancer Institute-designated comprehensive cancer center , high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center , gold level 1 geriatric emergency department and regional burn center . UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County.

To learn more about UCI Health, visit

Position Summary:

Reporting to the Regulatory and Compliance Manager, incumbent serves as a subject matter expert in Transfusion Medicine, Laboratory and Pathology Medicine regulatory affairs and quality assurance, providing consultative services for department leaders. The Regulatory and Quality Assurance Specialist is responsible for ensuring compliance with all applicable federal, state, and accreditation regulations governing clinical laboratory and pathology operations. The incumbent supports quality assurance programs, regulatory compliance initiatives, and continuous improvement efforts to maintain the highest standards of patient care and laboratory performance. The specialist collaborates with laboratory leadership, technical staff, and external regulatory agencies to ensure the department meets all regulatory requirements and quality standards.

Required Qualifications:

• Must possess the skill, knowledge and ability essential to the successful performance of assigned duties
• Must demonstrate customer service skills appropriate to the job
• Minimum of 5 years of experience in a clinical laboratory setting, with a strong focus on regulatory compliance and quality assurance.
• Familiar with Microsoft Office applications
• Extensive experience with instrument troubleshooting, repair, testing and verification of system integrity.
• Excellent written and verbal communication skills in English
• Comprehensive understanding of laboratory regulations and accreditation standards (CLIA, CAP, FDA, AABB, Joint Commission, CA DPH etc.)
• Bachelor’s degree in Medical Laboratory Science, Biological Science, Healthcare Administration, or a related field.
• Advanced knowledge and experience/expertise in related field
• Ability to maintain a work pace appropriate to the workload
• Ability to design, administer and critically evaluate policies, procedures and processes against regulatory requirements

Preferred Qualifications:

• Master’s degree or Certification in Quality or Regulatory Affairs (e.g., ASQ, CQA, RAC)
• Experience in an academic medical center or large hospital laboratory is highly desirable.

Licenses and Certifications:

• Clinical Laboratory Scientist

Education:

We offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits .

Conditions of Employment:

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:

• Background Check and Live Scan
• Employment Misconduct*
• Legal Right to Work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

*Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy may be reviewed by visiting the following page:

The University of California is 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, disability, age, protected veteran status, or other protected categories covered by the UC Anti-Discrimination Policy .
We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact UCI's Employee Experience Center (EEC) at [email protected] or at (949) 824-0500, Monday - Friday from 8:30 a.m. - 5:00 p.m.

Job Tags

Similar Jobs