Job Details

Requisition Details

GENERAL REQUISITION INFORMATION

EEO Statement:

UNMC is an Equal Employment Opportunity Employer, including an equal opportunity employer of protected veterans and individuals with disabilities.

Location
Omaha, NE

Requisition Number:
Staff_14257

Department
Assoc Vice Chancellor for Research 50001225

Business Unit
Vice Chancellor for Research

Reg-Temp
Full-Time Regular

Work Schedule
M-F 8-5

Remote/Telecommuting
No remote/telecommuting opportunity

Position 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.

Position Details

Additional Information

Posting Category
Healthcare

Working Title
Quality Assurance/Quality Control Specialist

Job Title
Quality Assurance/Quality Control Specialist

Salary Grade
HC25S

Appointment Type
B1 - REG MGR PROF SALARY

Salary Range
$69,400 - $104,100/annual

Job Requisition Begin Date
12/17/2025

Application Review Date
01/30/2026

Review Date Information:

Initial application review will begin on the date provided in the field above. Applications received prior to this review date will be considered. Applications received after the review date may be considered.

Required and Preferred Qualifications

Required Education:
Bachelor's degree

If any degree major/training is required, please specify the type. (NOTE: Concentration and minors are not equivalent to a major)

Health Sciences, Life Sciences, Nursing, or related field

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

Required Experience
3 years

If any experience is required, please specify what kind of experience:

QA/QC experience conducting audits, inspections, and/or quality monitoring activities in a clinical research, academic medicine, pharmaceutical/biotechnology or related setting.

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

Required License
No

If yes, what is the required licensure/certification?

Required Computer Applications:
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook

Required Other Computer Applications:

Required Additional Knowledge, Skills and Abilities:

• 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.

• 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).