Quality Assurance Specialist

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

This is a Hybrid position based out of RTP, NC.

Supports and assesses activities that ensure organizational adherence to corporate quality and compliance processes, including quality management systems reviews, data integrity assessments, and risk management assessments. Coordinates with donor centers and shared services with external inspections (e.g. regulatory, customer, etc.). Aids with audit planning, audit responses, and Plasma Master File (PMF) updates to maintain donor center compliance with regulatory requirements, Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP), and customer requirements.

• Evaluates and organizes multiple aspects of audit activity by performing the following duties:

• Prepares Site Master Files (SMFs) required for external EMA inspections through collaboration with donor centers and center support leadership.

• Represents organization by providing on‑site or remote support during inspections by Regulatory Authorities.

• Responsible for