Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences

• 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.
• 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.
• 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.

Requirements:

• Intermediate to advanced computer skill in Microsoft Word, Outlook, Excel.
• 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.