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 ProfessionalQuality 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.
Special Instructions to Applicants:
Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Review of applications will begin as soon as the job is posted and will continue until the position is filled.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references)
Bachelor's degree in a biological science is required, preferably in clinical laboratory science.
Laboratory certification by ABHI and/or ASCP (MT or SBB).
1 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.
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 regulations
Familiar with electronic document control systems
Knowledgeable of Microsoft Access
Capable of interacting professionally with fellow employees of all educational levels
Additional Salary Information: 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.
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.
Total Compensation Calculator: http://www.cu.edu/node/153125
Internal Number: 21179
About University of Colorado, ClinImmune Labs
The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002.
ClinImmune Labs is an educational business unit of the School of Medicine at the University of Colorado and is comprised of a Histocompatibility Laboratory, Stem Cell Processing Laboratory, two FDA licensed C...ord Blood Banks, Flow Cytometry Laboratory, and a research laboratory. ClinImmune Labs maintains accreditation with AABB, ASHI, FACT, and CAP. Due to ClinImmune Labs’ involvement in research and clinical trials within the University of Colorado Hospital and other entities, the environment is one of innovation and requires a high level of commitment to quality.