Drive quality assurance in QA Operations at Emergent in Winnipeg. As a Specialist I, you will oversee compliance in product distribution, batch records, and operational practices to ensure safety and quality.
The Specialist I role is critical for maintaining compliance at Emergent, supporting lot release and operational oversight. You'll manage QA reviews, deviations, and critical quality agreements, contributing to the production of protected products. This position requires engagement with cross-functional teams, ensuring adherence to GMP guidelines and enhancing quality systems.
Key Responsibilities:
• Coordinate quality oversight for lot and raw material releases
• Support operational compliance and good documentation practices
• Manage the distribution of commercial and clinical products
• Oversee deviations, CAPAs, and change control documentation
• Assist with quality systems and process improvements
Requirements:
• Bachelor’s degree and at least 5 years in relevant fields
• Deep understanding of GMP and regulatory expectations
• Experience in QA activities related to product release
• Strong documentation skills and data integrity knowledge
• Capable of making decisions in GMP settings
Contribute to Emergent’s mission of delivering quality life-saving solutions with your expertise in QA Operations.
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