Quality Analyst

Our Quality Assurance 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.

What You’ll Be Doing

• 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

What We Look For

• Advanced professional proficiency in English (oral and written) – mandatory

• 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

At 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.

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  Clario reserves the right to amend or change this job description to meet the needs of Clario.  This job description and any attachments do not constitute or represent a contract. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.