University Of Nebraska Medical Center
Quality Assurance/Quality Control Specialist
University Of Nebraska Medical Center, Omaha, Nebraska, us, 68197
Quality Assurance/Quality Control Specialist
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
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.
Job Title: Quality Assurance/Quality Control Specialist
Salary Grade: HC25S
Appointment Type: B1 - REG MGR PROF SALARY
Salary Range: $69,400 - $104,100/annual
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: 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 of 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
Required Computer Applications: Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
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.
Preferred Education: (none specified)
Preferred Experience:
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.
Preferred License: Yes
Preferred Licensure/Certification: 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])
Preferred Computer Applications: Microsoft Outlook
Preferred Additional Knowledge, Skills and Abilities:
Familiarity with electronic quality management systems (eQMS) and clinical trial management systems (CTMS).
Individuals who need accommodation during the online application or interview process may contact 402-559-4070 or jobs@unmc.edu to request an accommodation.
For questions regarding application, please contact UNMC Staffing at jobs@unmc.edu.
#J-18808-Ljbffr
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
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.
Job Title: Quality Assurance/Quality Control Specialist
Salary Grade: HC25S
Appointment Type: B1 - REG MGR PROF SALARY
Salary Range: $69,400 - $104,100/annual
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: 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 of 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
Required Computer Applications: Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
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.
Preferred Education: (none specified)
Preferred Experience:
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.
Preferred License: Yes
Preferred Licensure/Certification: 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])
Preferred Computer Applications: Microsoft Outlook
Preferred Additional Knowledge, Skills and Abilities:
Familiarity with electronic quality management systems (eQMS) and clinical trial management systems (CTMS).
Individuals who need accommodation during the online application or interview process may contact 402-559-4070 or jobs@unmc.edu to request an accommodation.
For questions regarding application, please contact UNMC Staffing at jobs@unmc.edu.
#J-18808-Ljbffr