Quality Assurance Specialist - IACUC Office

Department: IACUC Office

Salary/Grade: EXS/7

Job Summary:

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 recommendation, 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. The QA Specialist is responsible for working with IACUC Office leadership to identify potential program improvements through data analysis of QA outcomes to ensure that the IACUC and the Center for Comparative Medicine (CCM) facilities operate at optimum effectiveness and efficiency. This role also promotes the high ethical standards in the care and use of animals in research.

The IACUC Quality Assurance Specialist will support the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity.

Specific Responsibilities:

Operational Management

• 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.
• Supports the IACUC in ensuring compliance programs meet regulatory requirements and are in compliance with often changing and complex Federal, State, and local regulations regarding the activities of the department.
• Assists in the development and maintenance of compliance programs, including, but not limited to educational materials and presentations, associated forms/policies, and internal procedures.
• Serves as subject matter expert in IACUC and CCM policies, guidelines, procedures and SOP related to animal research.
• Contributes 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 the 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 of the eIACUC protocol management system.

Training and Analysis

• 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.
• Contributes to the analysis and creation of reports that track compliance issues related to Federal requirements.

Other

• Serve as a back-up for all IACUC office functions.
• Completes special projects as needed.
• Assist with routine and IACUC-directed site visits of all animal areas.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• 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.

• Flexible to 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 Certified.

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:

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include 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; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:

Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.

We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:

Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

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