This is a full time (100% FTE), University Staff (non-classified) Quality Assurance Coordinator position available at ClinImmune within the Division of Allergy and Clinical Immunology at the University of Colorado Anschutz Medical Campus. ClinImmune provides umbilical cord blood and tissue banking, clinical testing for human stem cell and organ transplants, stem cell product processing and infusion services, and histocompatibility and immunogenetics testing for human stem cell & organ transplantation. ClinImmune is also very involved with gene therapy research and development and flow cytometric testing. This position is responsible for supporting high level quality and regulatory operations, including research support to the ClinImmune faculty and staff in the areas of training, quality improvement/control, process development and regulatory compliance. 

Key Responsibilities:

• Participate in audit process for both internal and external entities, including the design and performance of internal audits, scheduling, coordinating, 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.
• Review master batch records, coordinate medical director review of product files, and approve cell therapy products for infusion.
• Review, complete, and submit accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), ASHI, CAP, AABB, AATB, and FACT. Approve and submit annual documentation of facility accreditation. Must maintain knowledge of current standards, work independently, and with quality manager, to educate and train staff on compliance with all standards.
• Assess updates to FDA regulations on human cells, tissues, and cellular and tissue-based products (HCT/Ps).
• 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 with guidance of management. Verify effectiveness of any corrective and preventative actions. Determine when an occurrence needs to be reported to the FDA as 3500a or 3486 BPDR.
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies that ClinImmune has taken on to assist clinical trials being performed by other University departments or is performing themselves.
• 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.

Must apply on the CU Careers website: https://cu.taleo.net/careersection/2/jobdetail.ftl?job=36151&lang=en

Minimum Qualifications:

Entry Level:

• A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.

Intermediate Level:

• A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
• One (1) year of professional level experience in a Quality Assurance position.

Senior Level:

• A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
• Two (2) years of professional level experience in a Quality Assurance position.

A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.

Applicants must meet minimum qualifications at the time of hire.

About ClinImmune

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. As an academic based biotechnology company, ClinImmune is committed to providing the highest quality service and support to clinical customers and researchers locally and abroad. Our prime location at the Un...iversity of Colorado Anschutz Medical Campus allows for collaboration with world-renowned clinicians and scientists. ClinImmune is an academic and clinical component of the University of Colorado Anschutz Medical Campus.

Show more

Show less

Connections working at ClinImmune