Quality Assurance Coordinator

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 Private Equity Round on 2019-10

Healthcare Insurance • Biotechnology • Artificial Intelligence

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• 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

🎯 Requirements

• 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).

🏖️ Benefits

• Competitive pay and incentives • Provident Fund and medical insurance • Engaging employee programs and local events • Modern office spaces and remote work flexibility