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.