Quality Assurance Coordinator

Job description

University of Colorado | CU Anschutz Medical Campus

School of Medicine, Division of Allergy and Clinical Immunology

Business Services Professional (Quality Assurance Coordinator)

Position # 00783333 REQ#: 21179

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

The Division of Allergy and Clinical Immunology has an opening for a full-time University Staff (unclassified) Business Services Professional Quality Assurance Coordinator position.

The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.

Nature of Work: 

This is a full time (100% FTE), University Staff (non-classified) Quality Assurance Coordinator position available at ClinImmune Labs within the Division of Allergy and Clinical Immunology at the University of Colorado Anschutz Medical Campus. The ClinImmune Labs provides tissue banking and clinical testing for human stem cell and organ transplants. This position is responsible for supporting general business operations, including research support to the ClinImmune Labs faculty and staff in the areas of training, quality improvement/control, and regulatory compliance.   

Professional Field: Quality Unit (QU) and Regulatory Affairs, Business Services

Supervision Exercised: None. 

Examples of Work Performed:

    Review, complete, and submit accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), ASHI, CAP, AABB, and FACT. Approve and submit annual documentation of facility accreditation. Must maintain knowledge of current standards and work with quality manager to educate and train staff on compliance with all standards.Organize and review quality systems including document control, internal and external audits, validations and verifications, IRB applications and continuing review, CAPA documentation and resolution, proficiency testing, and quality improvement.Oversee audit process for both internal and external entities, including the design and performance of internal audits, scheduling and coordinating audits, and providing resolution for deficiencies. Summarize and present audit results at quality review meetings.Maintain document control system, including “Master” and “Archived” files. In addition, review the staff training, annual continuing education requirements, competency, and SOP Reviews.Perform quality assessment and review of occurrences (CAPA). Utilize various recording and tracking systems (such as internal databases) to analyze events and determine appropriate resolution. Provide any necessary follow-up and/or documentation for process change requests and resolution.Review master batch records, coordinate medical director review of product files, and approve stem cell products for banking and release.
Salary and Benefits:

The salary range (or hiring range) for this position has been established at $44,526 to $66,790.  

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Benefits: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

Diversity and Equity:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected].

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Minimum Qualifications:

  • Bachelor's degree in a biological science is required, preferably in clinical laboratory science. 
  • Laboratory certification by ABHI and/or ASCP (MT or SBB).Quality certification1 year experience in HLA testing desirable
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.


Required: Applicants must meet minimum qualifications at the time of hire.

PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

Preferred Qualifications:

    1+ years of experience in quality management oversight and review. 
Knowledge, Skills, and Abilities:  

    Proficient with Microsoft Excel, Word, and PowerPoint Accrediting agency standards and regulationsFamiliar with electronic document control systemsKnowledgeable of Microsoft Access Capable of interacting professionally with fellow employees of all educational levels

Job Category: Business Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: May 6, 2021
Unposting Date: Ongoing




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Job No:
Posted: 5/7/2021
Application Due: 8/5/2021
Work Type: Full Time