Clario offers QA professionals like you the opportunity to make an impact globally. Read on to learn how you can grow your career while achieving a higher purpose!

We are seeking multiple QA Auditors to perform internal and external quality audits and assessments of our procedures and data to assure compliance and quality of our services and systems.

These are remote positions (with occasional travel for audits, as needed)!

What will you do?

• Support all audit/inspection types, including internal, external, vendor, regulatory inspections, and registrar (ISO, SOC, etc.), throughout all aspects and stages of the audits, including planning, conducting and reporting audits, all according to Clario's standards.

• Track and/or trend audit issues and/or CAPAs until closure, providing root cause guidance to CAPA owners and/or conducting root cause analysis when assigned.

• Champion timely management of quality event reports, audit findings, and CAPAs. Follows up and verifies effectiveness checks

• Identify and implement process improvements, with a focus on the audit program.

• Support the tracking and trending of all compliance reports and audit activities.

• Report on quality concerns and problems to key stakeholders as needed

• Perform QA review of source documents, case report forms (CRFs), and other reports for accuracy

• Work directly with Clario development teams to ensure the accuracy and consistency of system development and validation deliverables.

• Support external (vendor/supplier) quality audits and hosts Sponsor audits as needed

• Facilitate quality training of peers on quality-related matters as needed

What are we looking for?

• Associate's degree or equivalent required, ideally in life sciences, trial or quality management, or a similar field

• Quality and/or related certification (such as ASQ Auditor) is helpful

• Relevant experience and success in areas of Quality Assurance, Auditing, Validation, and/or SDLC systems in regulated industries (Pharma CRO, Biotech, Medical device preferred)

• Good knowledge of Good Clinical Practices (GCP), ICH Guidelines, Validation requirements and experience working with (or the ability to learn) quality management systems (QMS). Knowledgeable about 21 CFR Part 11, Annex 11, and other applicable ERES regulations

• Ability to work with all levels of Clario personnel and external personnel in a professional and organized manner, interacting and communicating effectively (spoken and written)

• Computer literate and familiar with most common software applications (i.e., Word, Excel, etc.)

• Understanding of medical and/or clinical trial terminology is desirable

• Ability to work independently and/or across cross-functional teams; ability to adjust to changing priorities

• Excellent attention to detail and orientation toward meticulous work

• Strong documentation and organizational skills; ability to manage multiple tasks effectively & efficiently. Proficient at problem-solving and goal-oriented

• Ability to project and maintain a professional and positive attitude, and possess high-level ethics and integrity

• Some (light) travel may be needed - perhaps up to 10%

• Strong preference for Midwest - West Coast candidates to support our West Coast team!

What can Clario offer you?

• Competitive compensation

• Attractive benefits (security, flexibility, support and well-being)

• Exceptional Tuition Program

• Engaging employee programs

• Friendly working culture

• The latest technology and home office set-up

At Clario, we value the contribution each of our people brings. We know that it's only through our people that we can continue to innovate technology that will shape the future of clinical trials!

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. All are welcome - join us!