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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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Sprachkenntnisse
- English
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