Quality Assurance Specialist

Job Summary

To support a global LabVantage LIMS implementation, the remote contract Quality Assurance Specialist - Change Controls will author, coordinate, and execute GMP-compliant change controls to ensure site readiness and successful system go-live.

Key Responsibilities

• Author and execute local change controls to support LabVantage deployment and go-live readiness
• Perform impact assessments across systems, data, processes, documentation, validation, and training
• Coordinate with cross-functional stakeholders to drive timely approvals and maintain change control trackers

Required Qualifications

• 5+ years of experience in GMP Quality Assurance within the pharma/biotech industry
• Proven experience authoring and executing change controls
• Working experience with LabVantage, specifically in Change Control processes and documentation
• Strong knowledge of document control and regulated environments
• Experience managing multiple parallel workstreams and stakeholders