Quality Assurance Specialist - CAPA & NC (Contract)

Phia LLC; Rolle; Hybrid; CHF 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Sickness and Accident coverage

Meal vouchers

25 days vacation

Free coffee and fruit

Zusammenfassung

SOPHiA GENETICS is seeking a Quality Associate for a contract role in Rolle, CH. You will support NC management, CAPA execution, and CCP activities as part of the Quality team, ensuring audit readiness and cross-functional collaboration.

You will handle end-to-end CAPA processes, maintain conformance documentation, and work with Supply Chain, Data Science and IT to drive timely outcomes. Fluency in English is required, and the role is hybrid with a start date ASAP.

Qualifikationen

• Experience in Quality Control / Quality Assurance in scientific, medical or pharmaceutical environments.
• Experience with ISO 9001 and ISO 13485 standards.
• Experience using Veeva and Jira for quality records and CAPA management.
• Fluent written and spoken English.

Aufgaben

• Review open and historical NCs to close gaps and ensure audit readiness.
• Manage CAPAs end-to-end from root cause analysis to verification.
• Support CCP activities with proper assessment, documentation, and approval.
• Collaborate with Supply Chain, Procurement, Data Science and IT to gather evidence and close actions on time.
• Identify emerging non-conformities, assess risk and recommend remediation.
• Maintain audit-ready records in Veeva and Jira throughout quality processes.

Kenntnisse

CAPA

NC

CCP

Quality documentation

Cross-functional collaboration

English proficiency

Tools

Veeva

JIRA

Jobbeschreibung

SOPHiA GENETICS is seeking a Quality Associate for a contract role in Rolle, CH. You will support NC management, CAPA execution, and CCP activities as part of the Quality team, ensuring audit readiness and cross-functional collaboration.

You will handle end-to-end CAPA processes, maintain conformance documentation, and work with Supply Chain, Data Science and IT to drive timely outcomes. Fluency in English is required, and the role is hybrid with a start date ASAP.