| Position Number: 00072479 | Working Title: Quality Assurance/Quality Control Specialist |
| Department Name: Assoc Vice Chancellor for Research UNMC | Reports To Title: Executive Director, Env Health & Safety |
| RESPONSIBILITY | TIME SPENT PERCENTAGE | ESSENTIAL FUNCTION | TASKS |
|---|---|---|---|
| Quality Oversight | 40 | X | Develop, implement, and maintain QA/QC systems that align with institutional policies, regulatory requirements (e.g., FDA, National Institutes of Health [NIH], Office for Human Research Protections [OHRP]), and accreditation standards. Conduct routine and for-cause audits of clinical research protocols, data integrity, regulatory binders, and informed consent processes. Provide quality monitoring for pre-clinical studies where applicable, including laboratory practices, data capture, and protocol adherence. Provide QA/QC oversight for IND and IDE-enabling studies, including review of investigational plans, preclinical data packages, and submission readiness assessments. Review informed consent forms (ICFs) for compliance with IRB, sponsor, and regulatory requirements. Provide guidance to investigators and study staff regarding corrective and preventive action (CAPA) plans. Support sponsor audits, regulatory inspections, and report quality indicators to leadership. |
| Compliance & Risk Management | 30 | X | Monitor adherence to GCP, GLP, Institutional Animal Care and Use Committee (IACUC), Institutional Review Board (IRB), Institutional Biosafety Committee (IBC) standards, and institutional Standard Operating Procedures (SOPs). Identify risks and coordinate CAPAs with research teams. Review IND and IDE submissions, amendments, and safety reports. Ensure appropriate QA review of IND and IDE submissions, amendments, and safety reporting to align with FDA requirements. Perform routine QC review of study source documents, case report forms (CRFs), and electronic data capture (EDC) systems to verify accuracy, completeness, and consistency. |
| Training & Education | 20 | X | Develop and deliver training programs for investigators, coordinators, and research staff on quality standards, regulatory expectations, and best practices. Serve as a resource for institutional leadership, providing consultation on QA/QC issues and evolving regulatory requirements. Develop and disseminate standard operating procedures (SOPs) and work instructions related to quality oversight. Provide targeted training on IND/IDE study requirements, including investigator responsibilities, sponsor obligations, and FDA inspection preparedness. |
| Collaboration, Communication & Continuous Improvement | 10 | Support process mapping, gap analyses, and workflow optimization projects that strengthen clinical and translational research infrastructure. Participate in institutional committees and quality initiatives to harmonize QA/QC practices across clinical and pre-clinical domains. |
Regulatory Knowledge: Demonstrated expertise in FDA regulations, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and related institutional and federal compliance standards. |
Problem-Solving & Risk Mitigation: Skilled at developing corrective and preventive action (CAPA) plans, resolving quality issues, and ensuring compliance under pressure. |
The role has significant impact on the institution’s ability to conduct compliant and ethical research. Failure to ensure quality oversight could lead to regulatory findings, clinical hold letters, withdrawal of FDA submissions, or suspension of studies. Such outcomes may result in financial loss, reputational damage, and legal liability. By proactively identifying risks and enforcing corrective actions, the Specialist mitigates liability exposure and strengthens the institution’s standing with regulators, sponsors, and accrediting bodies. |
How quickly is the overall correctness of the work of an incumbent in this position typically determined?:
Determined over a period of months |
Include budget dollars, value of assets, and impact in terms of organizational exposure to risk/liability.
Describe the budgetary accountabilities for this position:
Significant organizational risk and liability. |
What impact do the decisions/recommendations made by the position have on the department/campus?:
Compliance with federal guidelines. |
| TYPE OF CONTACT | LEVEL OF CONTACT | FREQUENCY OF CONTACT | PURPOSE OF CONTACT |
|---|---|---|---|
| Regulatory and Compliance Offices | Internal to UNMC | 2-3 times a week | Compliance and alignment |
| Investigator and study teams | Internal to UNMC | As needed | Direct interaction to review protocols, ensure compliance, deliver training, and provide feedback on quality issues. |
| External Auditors/Inspectors | External to UNMC | As needed | Represents the institution during FDA inspections, sponsor audits, and accreditation site visits, ensuring institutional preparedness and responsiveness. |
Daily to weekly touchpoints with supervisor |
Does this position supervise?:
No |
Type of Supervision Exercised:
NA |
Office,Lab,Other/ Combined |
If Other/Combined Environment, please explain:
Combination of laboratory and office |
| Sit: Frequently (34-66%) | Bending: Occasionally (1-33%) |
| Stand: Occasionally (1-33%) | Kneeling: Occasionally (1-33%) |
| Walk: Occasionally (1-33%) | Reaching: Occasionally (1-33%) |
| Drive Motor Vehicle: Not Required | Crawling: Not Required |
| Squatting: Not Required | Climbing: Not Required |
If other, please explain:
NA |
| Lift: Occasionally (1-33%) 10 lbs | Push: Occasionally (1-33%) 10 lbs |
| Carry: Occasionally (1-33%) 10 lbs | Pull: Occasionally (1-33%) 10 lbs |
If other Lift, Carry, Push, Pull, please explain:
NA |
| Animals (Category 1): NO | Moving Machinery: NO |
| Animals (Category 3): NO | Biohazardous Material: NO |
| Blood & Bloody Fluids: NO | Uncomfortable temperature/ humidity: NO |
| Radiation/ Radioactive: NO | Noise: NO |
| Chemical Hazards: NO | Working from Heights: NO |
| Electrical Hazards: NO | Confined Space: NO |
| 3B or Class 4 Laser: NO | Dust and Dusty environments: NO |
| Hot Work: NO |
If other exposure, please explain:
NA |
| Hearing Protection: NO | Eye Protection: NO |
| Half or Full Face Reusable Respirator: NO | Protective Clothing: NO |
If other protection, please explain:
NA |
| Keyboard: YES | Pipefitting: NO |
| Fine Manipulation: YES | Grasping: NO |
| Repetitive Motion: YES |
If other use of hands/ wrists, please explain:
NA |
| Ability to Speak: YES | Depth Perception: YES |
| Hearing: YES | Distant Vision: YES |
| Sight: YES | Near Vision: YES |
| Color Vision: NO | Peripheral Vision: YES |
During emergency conditions due to severe weather, natural disasters, major utility failures, or other unplanned events, certain personnel are activated to minimizethe impacts of emergencies and disasters, and to protect people, property, and restore the primary mission of the University of Nebraska Medical Center.These personnel occupy positions which are designated as 'Essential Positions.'
Essential:
| NO |