Quality Assurance Coordinator

This is a fully remote position, open to applicants in India.

📋 Description

• Facilitate and assist with pre-audit, audit, inspection, and post-inspection tasks under the guidance of Quality Assurance and Regulatory Compliance leadership.

• Arrange audits and inspections while overseeing logistics, timelines, and communications with stakeholders.

• Compile necessary documentation, supporting evidence, and schedules for subject matter experts.

• Partner with management and cross-functional teams to guarantee readiness for audits and inspections.

• Assess documentation for completeness and pinpoint gaps, risks, or missing information.

• Aid in acquiring, tracking, and organizing responses to findings from audits and observations from inspections.

• Sustain archives for audits and inspections, ensuring proper storage of documentation in specified repositories.

• Coordinate project documents, schedules, data requests, and stakeholder interactions for quality and regulatory compliance.

• Support libraries for audits and inspections as well as documentation for quality systems.

• Assist with special projects, initiatives for process improvement, and various quality-related tasks.

• Aid in global audit and inspection efforts across various time zones.

• Contribute to quality assurance, compliance, continuous improvement, and operational excellence.

⛳️ Requirements

• Associate’s degree, Bachelor’s degree, or a comparable combination of education, certifications, and relevant experience.

• 1–3 years of experience in a GxP-regulated environment or in another highly regulated sector.

• Willingness to operate in the US time zone, from 5pm to 2am.

• Experience in coordinating complex schedules, meetings, documentation, or project-related tasks.

• Familiarity with audits, regulatory inspections, quality systems, or compliance programs is preferred.

• Working knowledge of ICH GCP, 21 CFR Part 11, 21 CFR 820, ISO 9001, ISO 13485, ISO 27001, or similar frameworks is preferred.

• Proficiency in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Microsoft Teams.

• Strong organizational and project coordination abilities.

• Excellent written and verbal communication skills in English.

• Strong analytical capabilities, attention to detail, and a commitment to documentation accuracy.

• Experience with Quality Management Systems such as TrackWise or Veeva is a plus.

• Capability to work independently while effectively collaborating with global teams and stakeholders.

• Flexibility to occasionally work non-standard hours for global audits, inspections, and compliance tasks.

• Ability to thrive in deadline-driven environments while maintaining professionalism and quality.

🏝️ Benefits

• Competitive pay and incentives.

• Provident fund and medical insurance.

• Engaging employee programs and local events.

• Modern office environments and flexibility for remote work.

• Opportunities for professional development and advancement within a global organization.