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.
Skills Required
- Associate or Bachelor's degree or equivalent experience/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
- Knowledge of ICH GCP, 21 CFR Part 11, 21 CFR 820.20, ISO 9001, ISO 13485, ISO 27001
- 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
- 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)
Clario Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Clario and has not been reviewed or approved by Clario.
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Leave & Time Off Breadth — Time off is described as generous, including flexible PTO for some roles and up to 26–31 PTO days for eligible staff. The calendar includes 15 paid company holidays and a Winter Break.
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Healthcare Strength — Healthcare offerings include multiple medical plan options via Highmark with coordinated care navigation, plus dental and vision through established carriers. Employer HSA contributions and mental-health support broaden the package.
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Inclusive Benefits Coverage — Coverage highlights include domestic-partner eligibility, transgender-inclusive care, and HIV prevention/treatment. These inclusive elements are presented alongside broader inclusion commitments.
Clario Insights
What We Do
-- Clario has been named a Top Workplace by Energage for the 2022 Top Workplaces USA national awards. -- Clario generates the richest clinical evidence by fusing our deep scientific expertise and global scale into the broadest endpoint technology platform. By doing this, we empower our partners to transform lives. With almost 50 years of experience, 19,000 clinical trials, and 870 regulatory approvals, Clario has mastered the ability to generate rich evidence across a Trial Anywhere™ portfolio: decentralized (DCT), hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe, and Asia Pacific, Clario delivers the power of certainty. Partners ————— Clario brings the best of ERT and Bioclinica together to work alongside our partners to solve some of their biggest questions on topics such as: - eCOA vs. paper - Decentralized Clinical Trial (DCT) - Rescue a clinical trial - Broad endpoint technology: cardiac safety, imaging, respiratory And many more. People ———— We are so honoured to be named a 2022 Top Workplace by Energage. One of our leading values at Clario is People First Always. We help individuals build meaningful careers at Clario as they serve to help transform patients lives. Join us on this journey and check out our careers page: https://clario.com/careers/
