Responsibilities (included but not limited to):
• Provide QA support on the floor for production
• Ensure process control measures are in place and followed in product manufacturing
• Receipt and disposition of incoming apheresis material.
• Oversee and authorize shipment of final product
• Verify and ensure timely issuance of production documents and labels
• Review batch-related documentation and ensure resolution of issues to release and ship product.
• Gather and report metrics to measure performance
• Identify continuous improvement actions
• Ensure timely resolution and escalation of issues
• Ensure all product-related Deviations are initiated, investigated and resolved.
• Ensure that associated CAPAs are initiated and resolved, as needed.
• Perform lot closure activities.
• Ensure approval and timely delivery of final product.
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
• Perform other duties as assigned