Tekton Research

QA Engineer

• Conduct in-depth internal audits of clinical research activities, including investigator site files, informed consent processes, source documentation, and data integrity.
• Evaluate compliance with GCP, ICH guidelines, FDA/EMA regulations, and sponsor requirements.
• Oversee inspection readiness activities, including mock inspections, and act as a QA representative during regulatory inspections.
• Identify, evaluate, and manage quality risks across the site network, prioritizing areas for mitigation.
• Develop and oversee quality improvement plans to address systemic risks.
• Lead root cause analyses and the development of complex Corrective and Preventive Action (CAPA) plans.
• Monitor CAPA implementation, ensure effectiveness, and report outcomes to senior leadership.
• Design and implement site-wide quality improvement initiatives, ensuring alignment with industry best practices.
• Develop and update Standard Operating Procedures (SOPs), work instructions, and quality manuals.
• Provide QA team members and clinical staff with advanced quality assurance, regulatory compliance, and auditing training.
• Mentor junior and mid-level QA professionals, supporting their development and growth within the organization.
• Act as a subject matter expert in regulatory requirements, providing guidance to clinical operations, regulatory affairs, and other stakeholders.
• Collaborate with internal and external stakeholders to address quality-related issues and ensure trial integrity.
• Prepare comprehensive audit reports and executive summaries for leadership review.
• Analyze quality metrics to identify trends, opportunities for improvement, and areas of excellence.

Quality Assurance Specialist III