Regulatory Affairs Specialist at Katalyst Healthcares & Life Sciences
Hayward, CA 94540
About the Job
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
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.
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.
