Available Positions
Quality Assurance Coordinator (Entry – Senior Level) – 33462
This is a full time (100% FTE), University Staff (non-classified) Quality Assurance Coordinator position available at ClinImmune Cell & Gene Therapy within the Division of Allergy and Clinical Immunology at the University of Colorado Anschutz Medical Campus.
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 product (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.