Quality Assurance Coordinator

Join Clario, a part of Thermo Fisher Scientific and play a key role in supporting quality and regulatory compliance activities that help ensure the integrity of clinical research and healthcare technologies. As a Quality Assurance Coordinator, you will coordinate audit and inspection readiness activities, organize critical documentation and schedules, and partner with cross-functional stakeholders to support successful audits, regulatory inspections, and continuous quality improvement initiatives. This role is ideal for a highly organized professional who thrives in a collaborative, fast-paced, and regulated environment. What We Offer Competitive pay and incentives Provident fund and medical insurance Engaging employee programs and local events Modern office spaces and remote work flexibility Opportunities for professional development and growth within a global organization What You’ll Be Doing Coordinate and support pre-audit, audit, inspection, and post-inspection activities under the guidance of Quality Assurance and Regulatory Compliance leadership. Schedule audits and inspections and manage associated logistics, timelines, and stakeholder communications. Partner with audit and inspection hosts to organize required documentation, supporting evidence, and schedules for subject matter experts. Work collaboratively with management and cross-functional teams to ensure projects are audit and inspection ready. Review documentation for completeness and identify gaps, risks, or missing information that could impact audit readiness. Assist with obtaining, tracking, and organizing responses to preliminary audit findings and inspection observations. Maintain audit and inspection archives and ensure documentation is stored accurately within designated repositories. Coordinate project documents, schedules, data requests, and stakeholder activities associated with quality and regulatory compliance activities. Support the maintenance of audit and inspection libraries and related quality systems documentation. Assist with special projects, process improvement initiatives, and other quality-related activities as assigned. Support global audit and inspection activities that may require collaboration across multiple time zones. Contribute to a culture of quality, compliance, continuous improvement, and operational excellence. What We Look For Associate’s degree, Bachelor’s degree, or equivalent combination of education, certifications, and relevant experience. 1-3 years of experience in a GxP-regulated environment or other highly regulated industry. Candidates must be willing to work in the US time zone. (5pm to 2am) Experience coordinating complex schedules, meetings, documentation, or project-related activities. Exposure to audits, regulatory inspections, quality systems, or compliance programs is preferred. Working knowledge of regulatory and quality standards such as ICH GCP, 21 CFR Part 11, 21 CFR 820, ISO 9001, ISO 13485, ISO 27001, or related frameworks preferred. Proficiency with Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Microsoft Teams. Strong organizational and project coordination skills with the ability to manage multiple priorities and deadlines. Excellent written and verbal communication skills in English. Strong analytical skills, attention to detail, and commitment to documentation accuracy. Experience with Quality Management Systems (QMS) such as TrackWise or Veeva is an added advantage. Ability to work independently while collaborating effectively with global teams and stakeholders. Flexibility to periodically work non-standard hours in support of global audits, inspections, and compliance activities. Ability to perform successfully in deadline-driven environments while maintaining a high level of professionalism and quality. At Clario, a part of Thermo Fisher Scientific, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.