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Quality Specialist Document Controls

Foresite Capital companies: All the companies in their portfolio. Can see a bunch of them missing from hiring.cafe in here
onsite
Chile

About this role

About the Role

We are seeking a Quality Specialist – Document Controls to ensure documentation integrity and regulatory compliance for Signant Health's eClinical solutions. You will support document lifecycle management, change control, audits, and alignment with FDA/EMA regulatory requirements across global studies.

What You'll Do

  • Manage and maintain controlled documents (SOPs, work instructions, policies) and document retrieval processes to support audits.
  • Assist with change control, deviation investigations, CAPA, and regulatory requirements for FDA/EMA submissions.
  • Collaborate with cross-functional teams (QA, IT, clinical operations) to ensure document accuracy and compliance.
  • Support regulatory inspections and audit readiness activities.

What We're Looking For

  • Experience in quality/document controls within a regulated environment (FDA/EMA).

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