Quality Analyst
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Job Description
Quality Analyst ensuring integrity of clinical studies at Clario. Partnering with teams to manage quality events and CAPAs for clinical trials.
Responsibilities:
- 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
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
- Advanced professional proficiency in English (oral and written) – mandatory
Benefits:
- Health insurance
- Flexible work arrangements
- Professional development opportunities
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