Field Validation 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 remote position with up to 75% travel for candidates in the Central or East Coast of the United States.

Summary:

Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing.

Primary Responsibilities:

• Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
• • Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations.
• Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.
• Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries.
• Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
• Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
• • Writes test cases to validate critical control points, user requirements, and functional designs.
• Executes test cases as needed.
• Prepares validation reports for distribution.
• Ensures milestones and timelines are met on assigned projects.
• Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:
• • Prepares validation equipment for use at the Donor Center and for evaluation upon return.
• Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance,