Regulatory Affairs Specialist - Vista, CA

Regulatory Affairs Specialist - Vista, CA Location: CA-Vista, US Contract Type: Regular Full-Time Area: MANUFACTURING This position is 100% on-site at our Vista, CA facility. This position is responsible for handling time sensitive Regulatory documents in accordance with appropriate regulatory agencies and internal company procedures. It maintains 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 Spreadsheet; 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. Update and distribute annual facility FDA reports. Assist with regulatory submissions, annual reports, and regulatory responses. Assure 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. Coordinate 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. Perform 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. Coordinate training on deviation management procedures. Maintain a master library/database of all Deviation documents. Maintain secured filing and storage system for archived hard copies of Deviation Reports. Prepare/proof document content and formatting for all Deviation Reports. Coordinate with document authors, owners, and reviewers to resolve content and formatting. Maintain a master library/database of all SOPs, forms, job aids, and training documents. Maintain 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. Associate’s degree or equivalent. Benefits Pay scale of $80,546.00 - $120,819.00 for California based employees. This position is eligible to participate in up to 5% of the company bonus pool. Benefits include medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws. #J-18808-Ljbffr