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About
Join us as Clinical Quality Assurance Auditor and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards. A day in the life of a Clinical QA Auditor: Conduct and/or lead a variety of internal and GCP audits as requested by senior management Lead process audits and may participate as a co-auditor in more complex system audits Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement) Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter Provide GxP consultation and support to project teams and external clients Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings Required Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years'). Required Knowledge, Skills and Abilities: Thorough knowledge of GxP, with particular expertise in GCP, as well as applicable regional research regulations and guidelines. Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management Excellent oral and written communication skills Strong problem solving, risk assessment and impact analysis abilities Solid experience in root cause analysis Above average negotiation and conflict management skills Flexible and able to multi-task and prioritize competing demands/work load Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.
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