Tekton Research is looking for a remote Quality Assurance Specialist III to join our team.
Position: Quality Assurance Specialist III (Full-Time/Exempt)
The Quality Assurance (QA) Specialist III is a senior-level professional responsible for leading and advancing quality assurance efforts across a clinical research site network. This role involves overseeing complex audits, driving process improvement initiatives, managing compliance risks, and serving as a key resource for regulatory readiness. The QA Specialist III acts as a subject matter expert (SME) in clinical research compliance, providing strategic guidance to ensure the integrity of clinical trials and alignment with regulatory requirements.
Reports to: Quality Assurance Manager
Job Description:
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Conduct in-depth internal audits of clinical research activities, including investigator site files, informed consent processes, source documentation, and data integrity.
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Evaluate compliance with GCP, ICH guidelines, FDA/EMA regulations, and sponsor requirements.
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Oversee inspection readiness activities, including mock inspections, and act as a QA representative during regulatory inspections.
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Identify, evaluate, and manage quality risks across the site network, prioritizing areas for mitigation.
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Develop and oversee quality improvement plans to address systemic risks.
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Lead root cause analyses and the development of complex Corrective and Preventive Action (CAPA) plans.
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Monitor CAPA implementation, ensure effectiveness, and report outcomes to senior leadership.
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Design and implement site-wide quality improvement initiatives, ensuring alignment with industry best practices.
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Develop and update Standard Operating Procedures (SOPs), work instructions, and quality manuals.
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Provide QA team members and clinical staff with advanced quality assurance, regulatory compliance, and auditing training.
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Mentor junior and mid-level QA professionals, supporting their development and growth within the organization.
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Act as a subject matter expert in regulatory requirements, providing guidance to clinical operations, regulatory affairs, and other stakeholders.
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Collaborate with internal and external stakeholders to address quality-related issues and ensure trial integrity.
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Prepare comprehensive audit reports and executive summaries for leadership review.
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Analyze quality metrics to identify trends, opportunities for improvement, and areas of excellence.
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Other duties as assigned
Required Skills/Abilities:
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In-depth knowledge of GCP, FDA/EMA regulations, ICH guidelines, and clinical trial processes.
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Excellent written and oral communication, attention to detail, organizational and planning skills
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Ability to perform and maintain quality work while prioritizing and managing multiple deadlines
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Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
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Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), or similar platforms.
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Proven ability to conduct audits and prepare detailed audit reports.
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Demonstrated experience leading audits and managing regulatory inspections.
Education and Experience:
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Bachelor’s degree in Life Sciences, Health Sciences, or a related field (Master’s degree preferred).
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5–7 years of experience in quality assurance, clinical research, or regulatory compliance, with significant experience in a QA leadership role.
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Experience working in a multi-site clinical research organization or network.
Physical Requirements:
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Prolonged periods of sitting at a desk and working on a computer
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Approximately 50% travel, with the possibility of increased travel during peak periods or as project needs demand.
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Must be able to lift to 15 pounds at times
