Work Schedule
Other
Environmental Conditions
Office
Job Description
Join us as Quality Assurance Auditor II - And enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.
What You’ll Do:
• Conduct and/or lead a variety of GxP qualification and routine vendor audits, as requested by senior management, including but not limited to on-site, virtual and remote audits of service providers used in clinical trials with or without technology components
• Perform directed vendor audits
• May perform clinical investigator site
• Provide GxP consultation and support to internal and external clients
• Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings
Education and Experience:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous QA and GxP vendor auditing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’).
• Fluent in English, Spanish and Portuguese
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Solid knowledge of the clinical trial process
• Thorough knowledge of GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of GxP vendor audits to high standards required by management
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Effectively works independently or in a team environment
• Highly developed problem solving, risk assessment and impact analysis abilities
• Solid experience in root cause analysis and CAPA development
• Above average negotiation and conflict management skills
• Proven adaptability
• Strong organizational and time management skills including flexibility and ability to multi-task and prioritize competing demands/workload
• Strong computer skills; ability to learn and become proficient in appropriate systems
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
The following is a plus:
• Experience performing other types of QA audits or activities (e.g., investigator site audits, database audits, clinical study report audits, sample results tables, process improvement)
• Experience hosting client audits and/or regulatory inspections.
• Experience delivering training.
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.
Apply today to help us deliver tomorrow’s breakthrough.
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