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.