Quality Operations Specialist at Fusion Pharmaceuticals

Drive quality assurance at Fusion Pharmaceuticals in Hamilton, Ontario. This onsite Senior Specialist role focuses on quality oversight, ensuring compliance and patient safety in manufacturing processes.

As a Senior Specialist in Quality Operations, you will oversee daily quality standards and support manufacturing, packaging, and testing activities. Collaborating with Operations, QC, and Regulatory departments, you will implement effective quality-system processes and continuous improvements. Your responsibility includes executing investigations, managing compliance protocols, and training staff to uphold high-quality standards.

Key Responsibilities:

• Provide on-the-floor quality assurance during manufacturing

• Lead timely investigations using root-cause analysis

• Author and approve changes to processes and documentation

• Ensure completeness and readiness of quality records

• Coach operators on GMP and SOP compliance

Requirements:

• Bachelor's in life sciences or engineering; advanced degree preferred

• 4-7+ years in quality operations in regulated industries

• Strong knowledge of QMS and CAPA processes

• Familiarity with FDA and EU GMP regulations

• Detail-oriented with strong problem-solving skills

Make a significant impact on product quality and patient safety by applying your expertise at Fusion Pharmaceuticals in Hamilton.
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