Overview
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 position is 100% on-site at our Vista, CA facility.
Regulatory Affairs Specialist
Summary:
This position is responsible for handling time sensitive Regulatory documents in accordance with appropriate regulatory agencies and internal company procedures. This position will maintain appropriate documentation and files including but not limited to: Facility licensure, Error & Accident (Deviation) Reports, Deferred Donor List (DDL), Viral Marker Data Forms, Monthly Plasma Yields Spread Sheet, PPTA Epidemiology Data Spreadsheet, Doctor, Manager, and Physician Substitute Approval Letters, Final Disposition of Units, and Recalls.
Primary Responsibilities:
- Administrate Error and Accident (Deviation) procedure and process; perform all required data entry, paperwork, file maintenance, written and verbal communications, and follow up within the required time constraints.
- Oversight of data entries in the GBS DDL.
- Assist Regulatory Management with product deviation reporting to the FDA.
- Updates and distributes annual facility FDA reports.
- Assists with regulatory submissions, annual reports, and regulatory responses
- Assures that appropriate maintenance of registrations occurs including renewals, site registrations, supplements for change
- assist with compiling and submitting reportable events
- support regulatory agency audits
- assist with the review of product labels and commercial materials to prevent findings of non-compliance
- Receive and review monthly viral marker data information, maintain associated files; perform data entry and follow up with centers as needed.
- Create, review and mail Doctor, Manager, and Physician Substitute Approval Letters. Maintain associated files.
- Help management ensure compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to deviation management.
- Maintain updated CFR access for donor center and manufacturing operations.
- Coordinates Deviation management process to ensure timely reporting and closure for GBS whole blood, source plasma and manufacturing operations.
- Coordinate the recall procedure and process, contact centers for recall documentation. Coordinate customer communications with Customer Support for final disposition of product.
- Receive and review data for Look Back Reports and Post Donation Information Reports; generate and prepare associated customer notifications.
- Performs review of Deviation Reports and associated documentation to ensure completeness, including documented evidence of impact assessments as a part of risk management and completion of all CAPA actions required by the report have occurred.
- Coordinates training on deviation management procedures.
- Maintains a master library/database of all Deviation documents.
- Maintains secured filing and storage system for archived hard copies of Deviation Reports.
- Prepares/proofs document content and formatting for all Deviation Reports.
- Coordinates with document authors, owners, and reviewers to resolve content and formatting.
- Maintains a master library / database of all SOPs, forms, job aids, and training documents.
- Maintains secured filing and storage system for archived hard copy / controlled documentation.
- Additional duties as assigned by management.
Additional Responsibilities, Skills & Education:
- 5-10% Travel.
- Intermediate to advanced computer skill in Microsoft Word, Outlook, Excel.
- Cell Therapy or Cell Culture experience highly preferred.
- Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements.
- Excellent interpersonal and communication skill.
- Must possess customer service skills and display attention to detail.
- Experience with Deviation Management system a plus.
- Must be flexible and able to multi-task in a fast-paced environment, and team player.
- Must be able to proof work and identify non-standard format or wording and errors within documents.
- Associates degree or equivalent
