Senior Quality Auditor

As a Senior Quality Auditor at Precision, you will play a crucial role in ensuring compliance with regulations and company procedures for clinical projects. Your responsibilities will include: - Supporting the Quality Management System by managing SOPs, training, and CAPA - Processing and maintaining documentation for controlled documents - Developing and administering training for employees and consultants - Hosting client/sponsor audits and supporting regulatory inspections - Coordinating and conducting assessments of vendors, including vendor audits - Conducting internal audits of quality systems, investigator site audits, and trial master file audits - Participating in computer systems validation projects and systems change control process - Providing QA consultation and support to project teams - Managing reported quality issues and associated corrective and preventive actions - Monitoring quality systems for compliance risks and improvement opportunities - Maintaining Q&C trackers, databases, metrics, and files Qualifications required for this role include: - Minimum of 4 years of industry experience - Clinical research experience in a non-QA role - Working knowledge of GCP/ICH guidelines and FDA regulations - Bachelor's degree in a science, healthcare, or related field - Willingness to travel up to 25% domestically and/or internationally Preferred qualifications include experience in CRO, Pharmaceutical, or Medical device industries, QA certification, and familiarity with electronic clinical trial systems. You should possess excellent interpersonal and problem-solving skills, effective communication abilities, and proficiency in Microsoft Word, Excel, and PowerPoint. Additionally, you must demonstrate a customer service demeanor, collaboration, flexibility, teamwork, attention to detail, and the ability to work independently or in a team. Please note that any data provided during the application process will be handled according to our Privacy Policy. If you require accommodation for the application process or have any accessibility limitations, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. We are committed to maintaining the integrity of our recruitment process and caution against fraudulent job offers. Our organization follows a formal interview process with communication from our recruiting team and hiring managers before extending any job offers.,