- 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.
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Quality Assurance Coordinator - Aurora, United States - University of Colorado
Description
Quality Assurance Coordinator (Entry – Senior Level)-33462University Staff DescriptionUniversity of Colorado Anschutz Medical Campus
School of Medicine | Department of Medicine | Division of Allergy & Clinical Immunology | ClinImmune Cell & Gene Therapy
Job Title: Quality Assurance Coordinator (Entry – Senior Level)
Position # – Requisition #33462
Job Summary:
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. 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:
Work Location:
Onsite – this role is expected to work onsite and is located in Aurora, CO.
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