QA GCP Auditor II
We are building something EPIC. Evestia Clinical is a biotech-focused global CRO delivering authentic expertise and personalized support. We partner with clients to provide expert guidance through complex clinical trials in specialized areas, including Rare Disease, Oncology, Neurology, and Immunology. Here, you become a vital part of a global team delivering life-changing impact through clinical excellence. Our foundation is built on principles that define our identity. Innovation drives us to seek new solutions, while Excellence ensures high standards in every project. This is balanced by genuine Care, fostering a supportive culture for both our patients and our people. Above all, we champion Partnership, believing that working together— with trust and flexibility —is the key to our collective success. Our approach is agile and personalized, empowering you to find creative solutions. We offer a welcoming culture that values belonging, ensuring you have the environment needed to thrive and grow. If you are ready to change lives worldwide, join our team.
About the Role
A Quality Assurance Auditor II is responsible for conducting various types of routine and for cause audits including, but not limited to: site audits, trial master file audits, vendor audits, internal process audits, validation and database audits and documenting these audits within EvestiaClinical’s Clinical Trial Management System or shared drive. What will your job look like? Auditor II will conduct audits to ensure compliance with local and federal regulations, ICH GCP, Protocol and, where applicable, Evestia Clinical’s or Sponsor’s SOPs Auditors may assist in audit preparation prior to third party and regulatory audits Works under limited supervision, reporting to the Director of Quality Assurance and participates in project team audit follow up meetings to develop appropriate resolution plans or CAPAs Serves as a regulatory reference for Sponsors and Evestia Clinical staff Auditor II may host or participate in a qualification audit of Evestia Clinical and represent EvestiaClinical in a study Kick-off meeting Additional responsibilities include leading portions of New Employee training May assist Director of Quality Assurance in QA SOP development and other quality management activities such as participation or hosting of Quality by Design meetings Travel may average 1-3 audits per month in US and international locations What will you need to succeed? BA, BS or MS preferably in bio-scientific, health care or life sciences GCP experience is essential At least 4 years' experience as a GCP auditor, an on-site clinical monitor, or in system validation Previous auditing training or experience preferred ACRP CCRA, SoCRA CCRP, RAC, SQA GLP or GCP certified preferred Superior clinical auditing and/or monitoring skills, excellent decision-making skills, and sound judgment Current and working knowledge of Federal Regulations, ICH /GCP and applicable SOPs Computer skills and ability to learn and become proficient with Evestia Clinical’s Clinical Trial Management System and Microsoft Office Willingness to assist with tasks not specifically outlined in this description What we offer you in return? We believe that to do your best work, you need the best support. That’s why we care deeply about your well-being, personal development, and achieving a true work-life balance. Our comprehensive benefits package is carefully designed to align with our culture and values, ensuring it maximizes your positive experience working here. Here is a quick look at the benefits you can expect as a valued member of the Evestia Clinical team: Health Insurance: 99% employer-paid Dental & Vision Insurance: 100% employer-paid Short-Term & Long-Term Disability: 100% employer-paid Life Insurance Policy 401(k) Retirement Plan: 3% employer contribution Flexible and Hybrid Work Options Unlimited PTO for salaried staff 12 Corporate Holidays Employee Assistance Program (EAP) Wellness Program Learning & Development Stipend: Increases with tenure Charitable Match Program Wednesdays Catered Lunches (In-Office) Ready to Take the Next Step? Does joining Evestia Clinical and making a global impact excite you? Then it's time to apply! We are eager to meet ambitious candidates. Remember, we hire for potential and passion. Therefore if you feel you're a good fit but don't meet every single requirement, please submit your application anyway. We want to hear from you. Our Commitment to Inclusion and Diversity We are deeply proud of our people and the successes we achieve together. We actively seek out and hire individuals with diverse backgrounds, voices, beliefs, and perspectives to join our growing global workforce. At Evestia Clinical, we believe that each person is unique. We celebrate your individuality, knowing that diverse viewpoints fuel Innovation and drive Excellence. We foster true Partnership across our global teams, guided by genuine Care for our colleagues. Our managers are dedicated to upholding this inclusive environment in every aspect of employment—from hiring and promotion to training and benefits. It's who we are, it's what we do, it's what we care about. Equal Opportunity & Accessibility Evestia Clinical is an equal opportunity employer committed to diversity in the workplace. We ensure fair treatment of all applicants and employees, without discrimination based on actual or perceived race, color, creed, religion, national origin, age, sex, gender identity or expression, sexual orientation, disability, veteran status, or any other characteristic protected by applicable law. We are committed to providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Evestia Clinical and require an accommodation or special assistance during the application process, please notify our recruitment team by sending an email with your request to [email protected]