Our Quality Assurance Specialist plays a vital role in ensuring the integrity of our clinical studies and the safety of our participants. Working at the heart of our Quality Management System (QMS), this role partners closely with Clinical Operations, Data Management, and Safety teams to manage Quality Events and CAPAs that impact study conduct, data quality, and participant health. If you're passionate about quality and continuous improvement, we invite you to join us in transforming lives through better evidence. Manage Quality Events and CAPAs to address impacts to study conduct, data quality, and participant health and safety issues.
What We Offer
- Competitive compensation
- Private health insurance
- Engaging employee programs
- Flexible work schedules
- Attractive PTO plan
- Flex workspace
What You’ll Be Doing
Generate quality metrics and support process improvement initiatives within the Quality UnitImplement and maintain Quality Management Systems (QMS)Manage CAPA responses for internal / vendor audits and external audit observations; ensure timely follow-upDevelop and distribute KPIs and other key quality metricsCreate documentation for new workflows, procedures, training, and support materialsAssist with updates to Standard Work Instructions and SOPsPrioritize multiple QA tasks to align with corporate quality objectivesTrack deliverables and escalate issues when necessaryWhat We Look For
Bachelor’s degree in a scientific or technical field2–5 years of experience in a Quality Assurance role within an FDA-regulated environmentKnowledge of GDP, GCP, and regulatory frameworks (21 CFR Part 11, 21 CFR 820.20, ISO 9001 / 13485)Experience with QMS and CAPA processesProficiency in ExcelExceptional written and verbal communicationStrong attention to detail and organizational skillsAbility to work independently and collaborativelySkilled in editing, proofreading, and clear documentationAt 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.