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Clario

Transforming Lives by Unlocking Better Evidence | Decentralized clinical trials | Broadest endpoint technology

Quality Assurance Coordinator

QA EngineerQA EngineerFull TimeRemoteJuniorTeam 5,001-10,000Since 1973H1B SponsorCompany SiteLinkedIn

Location

India

Posted

1 day ago

Salary

0

Seniority

Junior

Associate Degree1 yr expEnglishGoogle Cloud Platform

Job Description

Quality Assurance Coordinator

Clario

• 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

Job 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

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