Quality Assurance Specialist

About the role

The Quality Assurance Specialist will support Xcene Research in establishing and maintaining a compliant, user‑friendly system for managing clinical quality documents. This entry‑level position works closely with the CQA team to ensure all clinical trial processes meet regulatory standards.

Key responsibilities

• Implement and manage a practical system for Clinical Quality Documents (QDs) throughout their lifecycle.
• Develop, review, release, and retire QDs, ensuring they are current and accessible on an electronic platform.
• Support staff training on GCP, QA, risk management, and QD usage, and maintain training records.
• Participate in trial teams, attend meetings, and act as a GCP consultant for clinical staff.
• Identify and communicate potential risks in trial management and contribute to QA sections of Clinical Development Plans.
• Lead or assist internal quality audits, CAPA activities, production support, and quality management reviews.
• Conduct vendor and contract auditor assessments, ensuring compliance with sponsor protocols, GCP, ISO, and ICH guidelines.

Required profile

• Entry‑level qualification with up to 12 months of relevant experience.
• Strong understanding of clinical quality management and regulatory compliance.
• Ability to work collaboratively within multidisciplinary trial teams.

Required skills

• Good Clinical Practice (GCP)
• CAPA (Corrective and Preventive Actions)
• ISO standards
• ICH guidelines
• Clinical trial management