Quality Assurance Specialist - IACUC Office
Department: IACUC Office
About the Role
The Quality Assurance (QA) Specialist is primarily responsible for ensuring that the various research compliance activities within the Northwestern University (NU) animal care program adhere to Federal, State, and local regulations, AAALAC recommendations, as well as institutional policies, guidelines, and standard operating procedures (SOPs). The QA Specialist supports the IACUC Office through post-approval and for-cause auditing of complex research activities involving animals and manages minor incidents of noncompliance, including developing and implementing corrective action plans under IACUC delegated authority. This role promotes high ethical standards in the care and use of animals in research and supports the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity.
Responsibilities
- Lead quality assurance audits to ensure congruence with approved protocols and regulatory standards.
- Independently manage and resolve minor noncompliance incidents under IACUC delegated authority, including development and implementation of corrective action plans.
- Monitor animal use protocols for compliance with Northwestern policies and all Federal, State, and local regulations.
- Develop and maintain QA documentation and records.
- Prepare and present detailed reports summarizing audit findings, non-compliance investigations, and assessments of internal systems/process audits to assure compliance with SOPs, IACUC Policies, and applicable regulations and guidelines.
- Support the IACUC in ensuring compliance programs meet regulatory requirements and adapt to often changing and complex Federal, State, and local regulations.
- Assist in the development and maintenance of compliance programs, including educational materials, presentations, associated forms/policies, and internal procedures.
- Serve as a subject matter expert in IACUC and CCM policies, guidelines, procedures, and SOPs related to animal research.
- Contribute to the development of quality assurance initiatives.
- Participate in the development and revision of policies for the compliance component of the IACUC Office.
- Support IACUC monthly and subcommittees, including the Policy Subcommittee, to ensure meetings run smoothly and efficiently.
- Collaborate with stakeholders to develop and implement quality assurance initiatives that promote high standards of animal care.
- Assist faculty and staff with de novo submission preparation and procedure library clean-up through familiarity with the eIACUC protocol management system.
- Design and deliver training sessions for faculty, staff, and students on IACUC policies, procedures, and regulatory requirements.
- Advise investigators and staff on regulatory requirements, protocol flexibility, and best practices to maintain compliance.
- Monitor trends in noncompliance, identify opportunities to prevent noncompliance, and contribute to educational initiatives that promote ethical research practices.
- Contribute to the analysis and creation of reports that track compliance issues related to Federal requirements.
- Serve as a back-up for all IACUC office functions.
- Complete special projects as needed.
- Assist with routine and IACUC-directed site visits of all animal areas.
- Perform other duties as assigned.
Requirements
- A bachelor’s degree in a scientific, healthcare, or related field or the equivalent combination of education and experience where similar knowledge, skills, and abilities were acquired.
- 3+ years of relevant experience, including demonstrated knowledge of Federal, State, and local regulations governing the use of animal subjects in research.
- Knowledge of organization and research regulations.
- Experience working with animals in veterinary or research settings.
- Experience working with the IACUC and a desire to advance in the IACUC Office.
- Flexibility to meet laboratory needs and scheduling.
Preferred Qualifications
- Working knowledge of how research labs operate, writing protocols, and grants.
- Background working in a medical department or research lab.
- CPIA certification.
Pay
Target hiring range for this position will be between $67,000-$78,000 per year. Offered salary will be determined by the applicant’s education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.
Benefits
- Health, dental, vision, disability, and life insurance.
- Paid vacation and holidays.
- Paid medical/sick and parental leave.
- Tuition benefits for the employee and dependents.
- Pre-tax and flex spending accounts for commuting and dependent care.
- Generous retirement savings options.
- Wellness programs.
- Comprehensive work-life and wellness programs, including support for childcare and senior/adult care.
- Professional growth and development resources, including career development tools and educational opportunities.