Associate, Quality Records

What You Will Achieve

• Ensure compliant execution of electronic workflows, records governance, and document management for R&D Vaccines programs.
• Administer electronic document management (GDMS, Gnosis, Veeva, Val Genesis): coordinate reports/archives/procedural documentation; manage user access, governance, and compliance.
• Manage ELNs (Revvity Signals, GLP Signals) including compliance monitoring.
• Drive continuous improvement by streamlining workflows and automating manual processes using AI/digital solutions.

• Manage electronic workflows for creation/review/approval/archiving of controlled documents.
• Perform document control: metadata, version control, status tracking, lifecycle management.

• Ensure compliance with GLP/GCLP and regulatory/department records management requirements.
• Support audit readiness and data integrity initiatives.
• Maintain records per regulatory/business retention requirements.

• Administer ELN operations: user access, onboarding, troubleshooting, compliance monitoring, templates, enhancements.
• Partner to resolve system issues and improve systems.

• Provide training/guidance/support on document management, documentation practices, and compliance.
• Facilitate knowledge transfer and adoption.

• Bachelor’s degree (scientific/technical/business or relevant).
• Advanced Microsoft Office (Word/Excel/PowerPoint) and Adobe Acrobat Professional.
• Digital fluency; strong aptitude for AI-enabled/digital process improvement.
• Strong communication skills.
• Excellent organization/time management; manage multiple priorities.
• Self-motivated, collaborative.
• High attention to detail and data integrity.

• Experience in highly regulated environments (pharma/biotech/medical device/life sciences).
• Experience with GDMS/Veeva Vault/Val Genesis/Gnosis or similar.
• Knowledge of GxP electronic workflows, document control, records management, archiving (GLP/GCP/GCLP).
• Experience with AI-assisted tools/automation/digital productivity platforms.

Hybrid

• Base salary: $64,600–$107,600; bonus target 7.5%.
• 401(k) with company match and retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental & medical leave; medical/prescription/dental/vision.