Quality Assurance Coordinator

Join Clario, a part of Thermo Fisher Scientific as a Quality Assurance Coordinator supporting global audit and regulatory inspection readiness across a highly regulated environment. In this role, you will play a critical part in coordinating audit and inspection activities, ensuring documentation, schedules, and stakeholders are aligned to support compliance and operational excellence. This position requires strong organization, attention to detail, and the ability to collaborate across global teams while managing deadlines and multiple priorities.

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

What You’ll Be Doing

• Coordinate and support pre- and post-audit and inspection activities under the guidance of QA leadership

• Schedule audits and inspections, ensuring availability of key stakeholders and subject matter experts

• Partner with audit/inspection hosts to organize required documentation and ensure readiness

• Collaborate with cross-functional teams to maintain audit- and inspection-ready processes

• Identify documentation gaps and report findings to appropriate stakeholders

• Support preparation and coordination of preliminary audit response activities

• Maintain and organize audit and inspection documentation within designated repositories

• Assist in maintaining audit and inspection libraries and supporting related QA projects

• Participate in audit or inspection activities, including potential travel to support on-site needs when required

• Operate effectively across different time zones to support global processes

What We Look For

• Associate or Bachelor’s degree and/or equivalent experience or certifications

• Minimum 1 year experience in a GxP-regulated or highly regulated environment

• Experience supporting complex scheduling activities in a fast-paced environment

• Exposure to audits or regulatory inspections preferred

• Knowledge of regulatory standards including ICH GCP, 21 CFR Part 11, 21 CFR 820.20, ISO 9001, ISO 13485, and ISO 27001 preferred

• Strong organizational, analytical, and communication skills

• Ability to manage multiple priorities and meet deadlines in a global environment

• Detail-oriented with strong written documentation skills

• Proficiency in MS Office suite and Microsoft Teams for collaboration and reporting

• Ability to work independently and as part of a cross-functional team

• Flexibility to work occasional non-standard hours aligned to global operations

• Strong English language proficiency (written and verbal)

At Clario, 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.