QA Compliance Specialist in Plasma Operations
E
Emergent BioSolutions
📍 winnipeg, mb, Canada
Job Description
Enhance patient safety by ensuring compliance at plasma operations as a Specialist I, QA Compliance. This role involves oversight of quality systems in a fast-paced pharmaceutical setting.
As a Specialist I at our organization, you will leverage your expertise in cGMP regulations and quality assurance to support hyperimmune pharmaceutical manufacturing. Your role will include conducting quality system audits, maintaining inspection readiness, and collaborating cross-functionally to drive continuous improvement initiatives. Strong analytical skills and a solid understanding of compliance are essential for success.
Key Responsibilities:
• Provide QA oversight of plasma sourcing and handling
• Conduct quality audits for compliance verification
• Analyze records for adherence to GxP regulations
• Communicate metrics and trends to senior leadership
• Support regulatory inspections and responses
Requirements:
• Bachelor’s degree in Biological Science or similar
...
As a Specialist I at our organization, you will leverage your expertise in cGMP regulations and quality assurance to support hyperimmune pharmaceutical manufacturing. Your role will include conducting quality system audits, maintaining inspection readiness, and collaborating cross-functionally to drive continuous improvement initiatives. Strong analytical skills and a solid understanding of compliance are essential for success.
Key Responsibilities:
• Provide QA oversight of plasma sourcing and handling
• Conduct quality audits for compliance verification
• Analyze records for adherence to GxP regulations
• Communicate metrics and trends to senior leadership
• Support regulatory inspections and responses
Requirements:
• Bachelor’s degree in Biological Science or similar
...