Qa Auditor Jobs

• Manage corrective action and preventive action responses received for internal and vendor audits, and responses defined for external audit observations. Conduct follow-up with the applicable departments to ensure timelines for corrective actions are met
• System Requirements
• Assist with the hosting and management of client audits.
• Perform tracking/trending analysis of audit findings
• Perform internal audits and gap analyses of Clario’s operational and technical departments and processes to ensure compliance with Clario SOPs, Good Clinical Practices, and EN ISO 9001/ISO 13485 and applicable regulatory requirements. This includes all processes related to Clario’s System Development Life Cycle
• Perform audits of Clario’s vendors to assess their Quality Management System, and their ability to meet Clario contractual agreements, Clario quality standards, and applicable regulations
• Medical Device Development/Change Control
• Support Continuous Improvement program and conduct internal meetings to support management of issues
• Analyze any observations identified and work with applicable departments to generate effective corrective and preventive action responses
• Testing/Validation Records
• Develop auditing plans and compile reports for assigned audits
• System Maintenance Records
• Perform quality reviews to ensure the data and processes implemented by Clario are compliant with applicable regulations, guidelines, and internal procedures. This includes quality reviews of primary study documentation including raw data, reports, data listings, and FDA XML file deliverables as well as the establishment and training of ECG measurement criteria and alert ranges
• Perform quality reviews of key documents defined by Clario’s System Development Life Cycle specifically related to:
• Installation Qualification
• Migration Records

• Assist in the development or execution of system testing as required. Participation in this task may only occur if the Quality Assurance Auditor is not assigned to the project in an audit role
• Provide Annual Quality Assurance/Regulatory Affairs Training Courses to Clario staff, as necessary
• Author Quality Assurance/Regulatory Affairs standard operating procedures as required
• Provide consulting services to contracted external sources as required

• College (4-year) degree in Health/Life Sciences.

• Ability and willingness to travel at least 10-15% of the time (international and domestic)
• Competent computer skills
• Excellent leadership, analytical, organizational and communication skills
• Detail oriented
• Minimum 2 years experience in a Quality Assurance capacity with a focus on GCPs and previous auditing experience GMPs/experience with medical devices is a plus
• Ability to write concise and accurate audit reports
• Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities

Courageously Curious

Our appetite to blend the best of domain expertise, technology and human understanding knows no bounds. We’re relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions.

Behaviors:

• We partner' with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Deliver Exceptional
• We learn; embracing change, questioning how we work, finding a better way. And if it doesn't go to plan, we don't blame each other; instead, we own it and grow together

We step forward because responsibility powers us; we don’t leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other.

Behaviors:

• We prioritize; focusing on what matters, never compromising on quality.
• We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., People first, always

We think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patients—and each other. We’re united by our purpose—it’s why we go above and beyond to support each other, emphatically.

Behaviors:

• We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed.
• We do the right thing; for our customers, patients, sites and each other. And We're passionate about it.