enGene

QA Engineer

• Perform batch record review and facility issue resolution with GMP partner sites (CDMO).
• Conduct final disposition of clinical and commercial drug product, ensuring that disposition is conducted in compliance with applicable regulations and requirements. Includes coordination with QPs as required.
• Manage processes for demonstrated quality oversight of GMP partner sites, including partner investigations, CAPA and change controls. Identify and communicate quality and compliance risks to senior quality management and participate in determination of appropriate plan to address such risks.
• Support GMP inspections and audits at company’s GMP partner sites.
• Support the development and maintenance of procedures and quality systems for GMP operations.
• Support compilation of quality performance and compliance metrices as relates to product disposition and GMP partner site operations.
• Responsible for providing operational support for key quality systems (e.g. risk management, complaints, document management, training, and change control).
• Trend metrics related to non-conformances/CAPAS, training compliance at partner sites along with product disposition metrics.
• Represent quality input at internal cross functional and CDMO meetings.

Senior Specialist, Quality Assurance Operations