Quality Assurance Coordinator
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Job Description
Quality Assurance Coordinator supporting Clario’s clinical research and healthcare technology quality compliance. Coordinating audits, inspections, documentation, schedules, and regulatory readiness.
Responsibilities:
- Coordinate and support pre-audit, audit, inspection, and post-inspection activities under Quality Assurance and Regulatory Compliance leadership
- Schedule audits and inspections and manage logistics, timelines, and stakeholder communications
- Organize required documentation, supporting evidence, and subject matter expert schedules
- Collaborate with management and cross-functional teams to ensure audit and inspection readiness
- Review documentation for completeness and identify gaps, risks, or missing information
- Assist with obtaining, tracking, and organizing responses to preliminary audit findings and inspection observations
- Maintain audit and inspection archives and accurately store documentation in designated repositories
- Coordinate project documents, schedules, data requests, and stakeholder activities for quality and regulatory compliance activities
- Support audit and inspection libraries and related quality systems documentation
- Assist with special projects, process improvement initiatives, and other quality-related activities
- Support global audit and inspection activities requiring collaboration across multiple time zones
- Contribute to quality, compliance, continuous improvement, and operational excellence
Requirements:
- Associate’s degree, Bachelor’s degree, or equivalent combination of education, certifications, and relevant experience
- Minimum 1 year of experience in a GxP-regulated environment or other highly regulated industry
- 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
- 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
Benefits:
- 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
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