Quality Assurance Unit Professional (Research Pro 3 - Quality Assurance)

Job Description for Quality Assurance Unit Professional

Reporting Structure: This is a non-management position within Experimental Surgical Services, which is part of the Department of Surgery, within the University of Minnesota Medical School, within the Academic Health Center at the University of Minnesota

General: Experimental Surgical Services is a preclinical research lab that performs non clinical research for the purpose of the research and development of medical devices, physician
training, new surgical techniques, and other academic projects requiring the use of large and small animal models. ESS serves as a core resource across the University to support
interdepartmental and intercollegiate cross disciplinary research goals. Additionally, ESS performs and supports externally sponsored research studies for regulatory applications
investigating patient safety.

Basic Function: This is a highly specialized and important role within the ESS laboratory. The Quality Assurance Unit Professional (QAU) coordinates auditing activities to ensure compliance
with ESS Standard Operating Procedures (SOPs), Good Laboratory Practices (GLP) and the International Organization for Standardization (ISO) guidance requirements for studies
performed in the ESS laboratory and partner laboratories across the University of Minnesota. The QAU performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training programs, data, documentation and report reviews. The QAU works cooperatively with the ESS Quality
Assurance Unit Partner.

Characteristic Duties and Responsibilities:

Quality Assurance Unit Duties - 100% effort

• Audits protocols, amendments, raw data, reports and supporting documentation for internal accuracy, consistency, and conformance with FDA regulations and laboratory
  SOPs.
• Performs phase inspections of ongoing study activities.
• Performs facility audits to ensure departmental compliance with regulations
• Oversees and assists with audits to assure laboratory consistency.
• Prepares, issues, and tracks reports of observations noted during audits and inspections.
• Applies a thorough understanding of compliance to a broad range of regulatory issues.
• Maintains digital files to support audit activities and reports.
• Assists in scheduling audits and assigning QAU resources to projects.
• Coordinates auditing activities and implements auditing systems to ensure compliance with GLP requirements.
• Identifies, evaluates, and implements best practices in Quality and regulatory guidance.
• Evaluates interdepartmental processes for improvement opportunities and proposes solutions.
• Helps design and develop risk-managed regulatory processes within the laboratory and partner University departments.
• Oversees and designs training systems; acts as a lead trainer for new and junior staff
• Drives project planning and implementation; acts as lead auditor on studies
• Solicits and gains support of staff, investigators and management through effective collaboration and negotiation; represents QA in workgroups.
• Evaluates interdepartmental processes for improvement opportunities and proposes
  solutions.
• Oversees and designs training systems; trains and qualifies trainers on internal processes and procedures.
• Communicates with sponsors/investigators regarding regulatory issues.
• Supervision Received: This position reports to the ESS Laboratory Associate Program Director.
• Supervision Exercised: This position works cooperatively with other ESS staff, Quality Assurance personnel and laboratory management.
  
  

Requirements:

* Bachelor's degree in a scientific discipline or equivalent combination of education
and experience plus at least four years of experience in a GLP-regulated environment, or advanced degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least eight years
* Professional certification (e.g., RQAP-GLP or ASQ-CQA) strongly preferred.
* Experience working in a matrixed, service-oriented research environment is highly
desired.
* Strong communication, negotiation, and project management skills.
* Proficiency in Microsoft Office applications and database entry.

Physical Demands:

• Must be able to sit or stand for extended periods, lift up to 50 lbs, and work in person
  weekly hours including core lab hours of 7:00 am - 3:30 pm, at least 4 days per week.
• Travel up to 10% may be required.

Non-Physical Demands:

• Ability to manage multiple service engagements and meet deadlines; strong analytical
  and documentation skills.

Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.

To learn more about the Department of Surgery, please visit https://med.umn.edu/surgery

Pay Range: $69,285-$82,000; depending on education/qualifications/experience

Time Appointment Category: 75%-100% Appointment (If job description above does not specify appointment or expected weekly hours, assume a 100% appointment.)

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• The University offers a comprehensive benefits package that includes:
• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).