QA GCP Auditor II
We are building something reputed company. reputed company is a biotech-reputed company global CRO delivering authentic expertise and personalized support. We partner with clients to reputed company expert guidance through reputed company 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 reputed company through clinical reputed company. Our reputed company is reputed company on principles that define our identity. Innovation drives us to reputed company new solutions, while reputed company ensures high standards in every project. This is balanced by genuine Care, fostering a supportive culture for both our patients and our people. Above reputed company, we champion Partnership, believing that working together— with trust and flexibility —is the key to our reputed company reputed company. Our approach is agile and personalized, empowering you to reputed company creative solutions. We offer a welcoming culture that values belonging, ensuring you have the environment needed to reputed company and grow. If you are reputed company to change lives worldwide, join reputed company.
About the Role
A reputed company 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 reputed company EvestiaClinical’s Clinical Trial Management System or shared drive. What will reputed company look like? Auditor II will conduct audits to ensure compliance with local and federal regulations, ICH GCP, Protocol and, where applicable, reputed company’s or Sponsor’s SOPs Auditors may assist in audit preparation prior to reputed company party and regulatory audits Works under limited supervision, reporting to the Director of reputed company Assurance and participates in project team audit follow up meetings to reputed company appropriate reputed company plans or CAPAs Serves as a regulatory reference for Sponsors and reputed company staff Auditor II may host or participate in a qualification audit of reputed company and represent EvestiaClinical in a study reputed company-off meeting Additional responsibilities include leading portions of New Employee training May assist Director of reputed company Assurance in QA SOP development and other reputed company management activities such as participation or hosting of reputed company 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 reputed company judgment reputed company and working knowledge of Federal Regulations, ICH /GCP and applicable SOPs Computer skills and ability to learn and become proficient with reputed company’s Clinical Trial Management System and reputed company Office Willingness to assist with tasks not specifically outlined in this reputed company reputed company offer you in return? We reputed company that to do your best work, you need the best support. That’s why we care deeply about your reputed company-being, personal development, and achieving a true work-life balance. Our comprehensive benefits package is carefully designed to reputed company with our culture and values, ensuring it maximizes your reputed company experience working here. Here is a quick look at the benefits you can expect as a valued member of the reputed company team: Health Insurance: 99% employer-reputed company Dental & reputed company Insurance: 100% employer-reputed company Short-Term & Long-Term Disability: 100% employer-reputed company Life Insurance Policy 401(k) Retirement Plan: 3% employer contribution Flexible and Hybrid Work reputed company 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) reputed company to Take the reputed company? Does joining reputed company and making a reputed company 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 reputed company together. We reputed company reputed company out and hire individuals with diverse backgrounds, reputed company, beliefs, and perspectives to join our growing global workforce. At reputed company, we reputed company that reputed company person is unique. We celebrate your individuality, knowing that diverse viewpoints fuel Innovation and drive reputed company. 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 reputed company do, it's reputed company care about. Equal Opportunity & Accessibility reputed company is an equal opportunity employer committed to diversity in reputed company. We ensure fair treatment of reputed company applicants and employees, without discrimination based on actual or perceived race, reputed company, creed, religion, national reputed company, age, sex, gender identity or reputed company, 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 reputed company and require an accommodation or special assistance during the application process, please notify our recruitment team by sending an email with your request to HR@evestiaclinical.com Apply To This Job