Quality Document Specialist

• Support the Quality Systems team within a pharmaceutical/biotech environment for a 6-12 month contract
• Manage controlled documentation and training processes, ensuring compliance with GxP standards
• Support audit readiness activities
• Process controlled documents (SOPs, Work Instructions, forms) through the Veeva Vault Quality Docs workflow
• Manage document metadata and ensure accuracy and completeness
• Route documents for review and approval in accordance with established procedures
• Execute periodic document reviews under the guidance of senior QA staff
• Assign and track training within Compliance Wire
• Monitor training completion and follow up on overdue assignments
• Troubleshoot user/learner issues and provide system support
• Maintain records in accordance with GxP retention requirements

• Associate’s or Bachelor’s degree in life sciences or a related field
• 2-4 years of experience in GxP Quality Assurance or document control within pharma/biotech
• Hands-on experience with Veeva Vault Quality Docs
• Experience with Compliance Wire or similar LMS platforms
• Familiarity with 21 CFR Parts 210, 211, and 11
• Understanding of Good Documentation Practices (GDP)
• Strong attention to detail and organizational skills
• Ability to manage multiple priorities in a fast-paced environment

Demonstrates expertise in managing controlled documentation and training processes within a GxP-compliant pharmaceutical or biotech environment, with a strong focus on accuracy and regulatory adherence.

• GxP Quality Assurance
• Veeva Vault Quality Docs
• Compliance Wire
• Document Control
• Good Documentation Practices

• Controlled Documentation Management
• Training Process Management
• Audit Readiness Support
• Document Metadata Management
• Periodic Document Reviews
• Troubleshooting User Issues
• Regulatory Compliance
• Document Processing
• Attention to Detail
• Organizational Skills

• Ability to Manage Multiple Priorities
• Strong Communication Skills

• Pharmaceutical
• Biotech
• GxP Standards
• 21 CFR Parts 210
• 21 CFR Parts 211
• 21 CFR Part 11
• Good Documentation Practices

• Veeva Vault Quality Docs
• Compliance Wire