Avispa · 23 hours ago
QA Document Control Specialist
Avispa is a leading biotechnology company seeking a QA Document Control Specialist to develop, deploy, and support the Veeva Quality Document System. The role involves managing and tracking all GMP documentation and ensuring compliance with established procedures.
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Responsibilities
Manage and maintain controlled documents in Electronic Document Management System (EDMS) ensuring documents go through controlled documents life cycle in accordance established procedures
Coordinate the review, finalization, and archival of Spark policies, procedures, and other controlled documents
Manage EasyVista (EV) on all incidents and requests for the EDMS and close all tickets in a timely manner
Serve as an administrator of the EDMS including user account management, system configuration, troubleshooting and work with EDMS vendor(s)
Qualification
Required
2-5 years of experience in working with documentation in a regulated industry
BS/BA in Biology, Chemistry, Engineering, related science discipline
Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
Knowledge of GMP concepts and guidelines
Experience with document control activities
Experience with document control systems
Effective knowledge of maintaining a document and data control system
A general understanding of FDA regulatory requirements as they relate to documentation
Extensive MS Word processing and formatting experience
Experience in automating processes utilizing MS Office products
Benefits
Group Medical
Dental
Vision
Life
Retirement Savings Program
PSL