Research Projects Coordinator
Core
Coordinate and administer the Quality Management System for the Cancer Immunotherapy Program, ensuring GMP compliance and supporting the production of CAR-T cells.
Role type
Quality Assurance Associate (Research Projects Coordinator)
Builds
CLIC CAR-T cells for the Canadian Lead Immunotherapies in Cancer network
Domain
Healthcare / Cell Therapy / Immunotherapy / GMP
Required skills
Quality Management Systems, vendor management, risk assessments, non-conformance/CAPA management, equipment qualifications, analytical qualifications, metrics compilation, software validations, internal auditing, regulatory standards knowledge (GMP, FACT, ISO 13485, ISO 14971, FDA 21 CFR 820, Health Canada)
Preferred skills
Clinical trials regulatory environment knowledge, cell therapy, immunology, immunotherapy, pharmaceuticals, electronic quality management systems (QPulse), statistical analysis
Technologies
Word, Excel, QPulse
Responsibilities
Maintain and control documents and records; develop and conduct quality training sessions; process routine deviations and manage change controls; oversee CAPA programs and root-cause investigations; perform vendor qualifications and risk assessments; review batch production records, assay qualifications, and environmental monitoring data; approve equipment qualifications; conduct internal facility audits; compile quality metrics and KPI trend reports; prepare documentation for regulatory submissions.
Seniority
Mid-level, hands-on IC