Essential Functions:

• Maintenance of the Quality Systems documentation in Veeva (electronic document control system) and other electronic systems where required.
• Perform document specialist functions in QA, including managing the lifecycle of GMP documents in Veeva, including creation, revision, approval, distribution and archival, ensuring compliance with internal procedures and regulatory standards.
• Work closely with quality assurance, external vendors, functional areas and Project Management team for daily management of routing, revisions, approval, and filing of documents within defined timelines.
• Organize and ensure accurate and reliable filing systems for all electronic and paper-based GMP documents.
• Support audits as appropriate (internal and regulatory).

Requirements:

• Bachelor’s BA/BS degree or equivalent experience.
• 2+ years of biopharmaceutical industry experience.
• Experience with managing key Quality Management System processes (e.g., Document Control, Change Management, Training).
• 2+ years of experience with document management utilizing EDMS systems, Experience with Veeva QualityDocs preferred. 
• Familiarity with documents and records associated with GxP manufacturing and testing activities.
• Understanding of current regulatory expectations including 21CFR Part 11 requirements.
• Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results.
• Strong professional interpersonal and communications skills, both verbal and written, to provide clear direction for the business, vendors, and internal stakeholders.
• Strong attention to detail, organizational skills, ability to work in a faced paced environment.
• Ability to meet deadlines and multi-task efficiently.
• Working knowledge with SmartSheet, Microsoft Office Suite, Word, Excel, PowerPoint, Visio, and Adobe.