QA Auditor II, Vendor Auditor

Job not on LinkedIn

🕒 April 24

🗣️🇪🇸 Spanish Required

🗣️🇧🇷🇵🇹 Portuguese Required

Apply Now
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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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

🎯 Requirements

• 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 • 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 • Strong organizational and time management skills including flexibility and ability to multi-task and prioritize competing demands/workload • Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.

🏖️ Benefits

• Health insurance • Paid time off • Professional development opportunities

Apply Now

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