Senior QA Specialist, Training and Document Management

Document Control

• Format and quality-check SOPs, work instructions, forms, and other controlled documents for compliance with approved templates, formatting standards, and document management procedures.
• Prepare documents and records in Veeva, maintain accurate metadata and version information, and route them through established review and approval workflows.
• Coordinate with authors, reviewers, and approvers to resolve administrative issues and follow up on outstanding workflow tasks.
• Process document issuance, effective dates, periodic reviews, revisions, obsolescence, and archival in accordance with approved procedures.
• Verify required administrative information, attachments, and approval records for completeness; escalate discrepancies to the appropriate owner.
• Maintain controlled templates and retrieve current or historical documents and records for business needs, audits, and inspections.
• Track and manage the periodic document review process.
• Improve documentation access and controls.
• Develop, document and update quality policies, procedures and work instructions.
• Identify opportunities to streamline document lifecycle management, improve electronic workflow efficiency, and reduce manual administrative activities.

Training Administration

• Administer training requirements, curricula, learner assignments, and associated records in Veeva in accordance with approved procedures.
• Coordinate onboarding and role-change training assignments with managers and process owners.
• Coordinate training assignments associated with new or revised controlled documents.
• Monitor training completion, issue reminders, follow up on overdue assignments, and escalate unresolved gaps.
• Maintain training completion records and generate training status reports and metrics.
• Provide routine user support for document and training workflows; escalate technical or configuration issues to the designated system administrator.
• Train GxP on documentation practices, quality standards, and system workflows.
• Identify training gaps and coordinate with department heads to resolve compliance risks.
• Perform onboarding of new hires in relation to their training responsibilities and introduction to Veeva.
• Perform annual curriculum review.
• Facilitate the escalation of and resolution for issues connected to the learning management system and/or external tools.

Quality Support and Continuous Improvement

• Support audit and inspections by organizing and retrieving document control and training records.
• Identify opportunities to improve document formatting, workflow turnaround, and training administration.
• Support approved process improvements and procedure updates.
• Manage assigned priorities independently, communicate deadlines, and promptly escalate potential compliance concerns.
• Compile quality metrics, track document/training KPIs, and generate reports for management review.
• Serve as a key Quality Systems resource for administration, maintenance, and continuous improvement of electronic document management and LMS platforms within Veeva.
• Support implementation, configuration, testing, and enhancement of electronic Quality Systems workflows in collaboration with system owners, IT, Validation, and business process stakeholders.
• Participate in user acceptance testing, change control assessments, procedural updates, and training activities associated with QMS system enhancements.
• Support the preparation of audit/inspection responses, investigation documentation, and CAPA commitments related to assigned Quality Systems processes.
• Promote a proactive culture of regulatory compliance, inspection readiness, and continuous improvement.