Job Title: Quality Systems Specialist
Location: 100% Remote
Contract Duration: 6 Months

Job Summary

We are seeking an experienced Quality Systems Specialist - Document Control & Change Management to support document control and change management activities within a regulated environment. This role will be responsible for coordinating document review and approval workflows, maintaining quality records, administering change controls, and ensuring compliance with quality system requirements.

Key Responsibilities

• Manage controlled documents through review, approval, issuance, and archival processes.
• Coordinate cross-functional document reviews and track approval timelines.
• Maintain accurate document control records and version management.
• Support change control activities within eQMS/EDMS platforms.
• Review change requests for completeness and route through approval workflows.
• Track change control actions, implementation activities, and closure milestones.
• Monitor document and change control status and provide stakeholder updates.
• Ensure documentation remains organized, compliant, and audit ready.
• Support process improvements and quality system compliance initiatives.

Required Qualifications

• Associate degree required, Bachelor's degree preferred.
• 5+ years of experience in Document Control, Quality Systems, Records Management, or Change Control within a regulated industry (Pharma, Biotech, Medical Device, etc.).
• Hands-on experience with Veeva Vault Quality Docs and other eQMS/EDMS platforms such as TrackWise, MasterControl, or SharePoint.
• Strong understanding of GMP, Good Documentation Practices (GDP), Document Control, and Change Control processes.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams).
• Excellent organizational, communication, and follow-up skills.

Preferred Experience

• Experience supporting Change Review Boards and quality governance processes.
• Additional experience with document and quality management systems in regulated environments.

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