Key Responsibilities
- Process controlled documents, including SOPs, work instructions, forms, and policies, through electronic workflow systems.
- Manage document metadata, routing, approvals, effective dates, and archival activities within Veeva Vault QualityDocs.
- Support periodic document review activities and maintain document control queues.
- Ensure compliance with internal document control procedures and GxP requirements.
- Assist with updates and revisions to Quality Management System documentation.
- Support change control activities and help drive the timely completion of document-related tasks.
- Identify opportunities for process improvements within Quality Systems operations.
- Assign and monitor GxP training activities within ComplianceWire.
- Track training completion and follow up with learners and functional teams.
- Troubleshoot user and learner issues related to training assignments and curricula.
- Assist with maintaining training curricula and course content.
- Escalate system integration, workflow, or configuration issues to system owners.
- Pull and organize document and training records for internal audits, client audits, and regulatory inspections.
- Maintain records in accordance with GxP and Good Documentation Practice (GDP) requirements.
- Support remediation and follow-up activities associated with audit observations
- Assist with inspection readiness activities, including back-room support and document retrieval.
- Support CAPA, non-conformance, and quality records management activities as needed.
Qualifications
- Bachelor’s degree in Life Sciences, Quality, Engineering, or related technical discipline.
- 2–4 years of experience in Quality Assurance, Quality Systems, or Document Control within the pharmaceutical or biotechnology industry
- Hands-on experience with Veeva Vault QualityDocs required
- Experience supporting ComplianceWire learning management systems preferred.
- Familiarity with FDA regulations, including 21 CFR Parts 210, 211, and 11.
- Exposure to CAPA, change controls, audit support, and inspection readiness activities
- Experience working within fast-paced, highly regulated environments
- Experience supporting pharmaceutical or biotech manufacturing and quality operations
- Understanding of Good Documentation Practices (GDP) and GxP requirements
- Strong organizational skills with the ability to manage multiple priorities and deadlines
- Proficiency with Microsoft Office applications and electronic document management systems
- Strong communication and collaboration skills with the ability to work cross-functionally in a regulated environment
