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University of Colorado · 5 months ago

Quality Assurance Coordinator (Entry – Senior Level)

Aurora, CO

Full-time

Hybrid

Entry, Mid, Senior Level

$57K/yr - $67K/yr

1+ years exp

The University of Colorado Anschutz Medical Campus is seeking a Quality Assurance Coordinator to support the mission and goals of ClinImmune and the School of Medicine. This role involves performing monitoring, auditing, and overseeing the quality of clinical laboratory testing, ensuring compliance with regulatory standards and delivering high-quality products for patient treatment.

EducationHigher EducationUniversities

No H1B

Responsibilities

Participates in regulatory submissions for Biological License Applications (BLA), filings, and communications with regulatory and accreditation agencies including audits including but not limited to the FDA, AABB, CAP, ASHI, FACT, and AATB and leads internal audits to ensure compliance

Oversees quality assurance in compliance with strict regulatory standards to make sure ClinImmune is delivering pure, and potent products for patient treatment and following proper laboratory protocols for patient sample testing and resulting. This requires laboratory oversight, and meeting regulatory agency requirements to ensure no harm can come to a patient

Reviews and assists with the preparation of occurrence (deviation) reports, complaints, and corrective and preventative actions (CAPA)

Recognizes and reports trends and opportunities for improvement (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are then shared with ClinImmune management and staff

Reviews supplier qualifications, inventory quality control functions, change control functions, as well as developing and implementing risk mitigation strategies for regulatory and accreditation compliance

Reviews and assists with validation and verification proposals and summaries for equipment, software, and/or processes to ensure that all contain appropriate testing to show the subject of the validation is fit for use

Performs review of cell and gene therapy product files and sponsor protocols, ensuring accurate documentation, donor eligibility review for correct labeling of products and product safety, and that regulatory, accreditation, and quality processes are being followed for all cellular therapy products administered to University of Colorado Hospital patients, whether standard of care cellular therapy products or sponsored cellular therapy clinical trials

Qualification

Quality assurance experienceRegulatory compliance knowledgeCellGene therapiesCertification in quality managementElectronic document controlClinical laboratory scienceCustomer service skillsCommunication skillsOrganization skillsDetail orientedTeamworkAdaptability