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 center support leadership and developing, writing, and reviewing external audit responses / CAPA plans related to donor center citations.
  • Responsible for developing, writing, and reviewing both internal and external audit responses / CAPA plans related to corporate citations.
  • Coordinates and organizes final responses to regulatory inspections / audits (FDA, EMA, CLIA/COLA, PPTA, State, Health Canada, internal compliance audits).
  • Supports donor centers with customer audits, completes requested customer‑driven documents, and assists with development of audit responses.
• Ensures donor center and corporate operations are compliant with Domestic / European regulations through routine procedure and process review.
• Recognizes areas of improvement through review of audit findings and offers solutions to enhance compliance to Domestic / European regulations, Standard Operating Procedures (SOP), and customer requirements.
• Evaluates the need for change and initiates Change Requests and writes Standard Operating Procedures based on trends, audit findings, or interaction with facilities.
• Assess Corporate deviations and tracking / trending data to ensure continuous improvement.
• Reviews Quality Risk Assessments and coordinates with center support leadership to ensure timely and accurate documentation and closure.
• Performs Data Integrity Risk Assessments.
• Represents the Department with organizational initiatives to ensure compliance with regulations, Standard Operating Procedures, and customer requirements.
• Travels up to 25% or greater if demand requires.

• The incumbent must have the ability to write clear, concise, logical responses to regulatory authorities.
• They must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
• They must know the European Pharmacopoeia (EP) and other European Guidelines as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).
• They must have strong interpersonal skills with the ability to communicate effectively with persons from other cultures and other points of view.

• Maintains a high level of professionalism.
• Follows policies, procedures, and regulations governing work and the work environment.
• Models and demonstrates high standards of integrity, trust, openness, and respect for others.
• Takes initiative; looks for opportunities to act and contribute to the team's success.
• Demonstrates good stewardship of expenses, makes good use of unsupervised time.
• Offers support to team members at any level in achieving their goals.
• Provides outstanding servant leadership and receives feedback constructively.
• Ap…