Quality Assurance/Quality Control Specialist

Job Summary:

The Quality Assurance/Quality Control (QA/QC) Specialist provides institution-wide support for quality assurance and quality control activities to ensure compliance with regulatory, accreditation, and institutional standards. This role focuses heavily on clinical research oversight, including compliance with Good Clinical Practice (GCP), while also supporting applicable pre-clinical research activities (e.g., Good Laboratory Practice [GLP], core facilities, and translational studies). The Specialist will play a critical role in supporting Investigational New Drug (IND) and Investigational Device Exemption (IDE)-enabling studies, ensuring documentation, data integrity, and regulatory submissions meet U.S. Food and Drug Administration (FDA) requirements. The QA/QC Specialist works collaboratively across departments, research teams, and administrative offices to strengthen a culture of quality, integrity, and continuous improvement in research operations.

Additional Info

About Us:

To learn more about the University of Nebraska, visit the sites below.

University of Nebraska Strategic Plan â??Odyssey to Extraordinaryâ? https://nebraska.edu/strategic-plan

Get to know Nebraska https://nebraska.edu/get-to-know-nebraska

University of Nebraska Medical Center Campus https://www.unmc.edu/aboutus/index.html and https://www.unmc.edu/aboutus/facts.html

University of Nebraska Faculty & Staff Benefits https://nebraska.edu/faculty-and-staff

Required Qualifications:

• Bachelor's degree in Health Sciences, Life Sciences, Nursing, or related field
• 3 years QA/QC experience conducting audits, inspections, and/or quality monitoring activities in a clinical research, academic medicine, pharmaceutical/biotechnology or related setting.
• Microsoft Outlook,Microsoft Excel,Microsoft Powerpoint, Microsoft Word

Will consider additional related post high school education in lieu of required experience.

 

• Demonstrated knowledge of GCP; familiarity with GLP and Good Manufacturing Practice (GMP) preferred.
• Strong understanding of regulatory frameworks (FDA, OHRP, NIH, IACUC/IRB requirements).
• Strong organizational skills with exceptional attention to detail.
• Effective written and verbal communication skills, with ability to collaborate across multidisciplinary teams.

 

Preferred Qualifications:

• Experience working within an academic medical center or hospital-based and/or complex research environment.
• Experience with IND and/or IDE submissions and related regulatory interactions.
• Certification in clinical research or quality (e.g., Association of Clinical Research Professionals [ACRP], Society of Clinical Research Associates [SOCRA], American Society for Quality [ASQ])

 

• Familiarity with electronic quality management systems (eQMS) and clinical trial management systems (CTMS).

 

Compliance Requirements:

• Background Check
• Education Credentials Check