Quality Assurance Specialist
The Quality Assurance Specialist is responsible for leading quality operations by supporting development of standard operating procedures, training oversight, manufacturing batch record review, management of deviations and CAPAs. The Specialist will also assist in qualifications, risk assessments, and audit activities. This role supports the overall quality culture and corporate objectives for regulatory compliance.
• Manage Document Control by actively supporting the development, revision, and approval of controlled documents.
• Monitor periodic review schedule and move documents through review process.
• Write, revise, and review standard operating procedures.
• Deliver quality operations training to new employees, oversee compliance with training requirements, and maintain training records for all employees.
• Review qualification protocols, process validations, calibration, and preventive maintenance records for completeness.
• Perform quality review of manufacturing batch records and in-process and release testing reports to ensure they are complete, accurate, and compliant with GMP requirements.
• Provide quality guidance for operations, qualifications, training, and document management.
• Manage the execution and completion of deviations, non-conformances, out of specifications, and CAPAs.
• Conduct internal audits.
• Other duties as required and directed by the relevant Manager
EDUCATION & CERTIFICATIONS
Bachelor’s degree in biology, chemistry, or a related scientific discipline
Training or certification in quality field preferred
WORK-RELATED SKILLS & EXPERIENCE
• 5-7 years work experience in quality system processes
• Knowledge of FDA and Health Canada regulations and standards (Biologics and Genetic Therapies Directorate Pt. C 1, 2, 5, 8), especially in the areas of cell therapy, bioanalytical testing, and clinical research [FACT/JACIE; ICH: Q2, Q7, Q10; FDA CFR 210, 211, 820, 1271]
• Working knowledge of QMS systems
• Proficient in MS Office
• Strong working knowledge of SharePoint and Adobe