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Transforming Lives by Unlocking Better Evidence | Decentralized clinical trials | Broadest endpoint technology
Quality Analyst
Location
Canada
Posted
79 days ago
Salary
0
Seniority
Mid Level
Job Description
Quality Analyst
Clario
• Generate quality metrics and support process improvement initiatives within the Quality Unit • Implement and maintain Quality Management Systems (QMS) • Manage CAPA responses for internal/vendor audits and external audit observations; ensure timely follow-up • Develop and distribute KPIs and other key quality metrics • Create documentation for new workflows, procedures, training, and support materials • Assist with updates to Standard Work Instructions and SOPs • Prioritize multiple QA tasks to align with corporate quality objectives • Track deliverables and escalate issues when necessary
Job Requirements
- Bachelor’s degree in a scientific or technical field
- 2–5 years of experience in a Quality Assurance role within an FDA-regulated environment
- Knowledge of GDP, GCP, and regulatory frameworks (21 CFR Part 11, 21 CFR 820.20, ISO 9001/13485)
- Experience with QMS and CAPA processes
- Proficiency in Excel
- Strong attention to detail and organizational skills
- Ability to work independently and collaboratively
- Skilled in editing, proofreading, and clear documentation.
Benefits
- Health insurance
- 401(k) matching
- Professional development opportunities
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