Quality Assurance Specialist III

🕒 6 days ago

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Tekton Research

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2006

💊 Pharmaceuticals

🤝 B2B

🧬 Biotechnology

💰 Private equity on 2023-10

Pharmaceuticals • B2B • Biotechnology

Tekton Research is a multi-site clinical research organization headquartered in Austin, TX that conducts Phase 1–4 clinical trials across neuroscience, cardiometabolic, infectious disease, and general medicine. The company partners with sponsors, CROs, and biopharma to develop drugs, medical devices, and diagnostics, operating a network of physician-led research sites across multiple U. S. states with rapid site activation, dedicated patient recruitment capabilities, and high participant retention. Tekton emphasizes patient-centered care while delivering operational scale for complex and high-volume trials.

📋 Description

• 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.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field (Master’s degree preferred). • 5–7 years of experience in quality assurance, clinical research, or regulatory compliance, with significant experience in a QA leadership role. • Experience working in a multi-site clinical research organization or network. • In-depth knowledge of GCP, FDA/EMA regulations, ICH guidelines, and clinical trial processes. • Excellent written and oral communication, attention to detail, organizational and planning skills. • Ability to perform and maintain quality work while prioritizing and managing multiple deadlines. • Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint). • Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), or similar platforms. • Proven ability to conduct audits and prepare detailed audit reports. • Demonstrated experience leading audits and managing regulatory inspections.

🏖️ Benefits

• Must be able to lift to 15 pounds at times • Approximately 50% travel, with the possibility of increased travel during peak periods or as project needs demand. • Prolonged periods of sitting at a desk and working on a computer