QA Clinical Auditor II

🔥 13 hours ago

🌐 Brazil, Colombia, +1 more countries – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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 client, internal, GCP, site, facility, vendor, and subcontractor audits • Participate in regulatory inspections as requested by senior management • Provide GCP consultation and support to project teams and external clients • Lead process audits and co-audit complex system audits • Perform QA activities including database audits, clinical study report audits, sample results tables, and process improvement • Serve as a QA and audit subject-matter resource to operational departments • Prepare and present audit findings and related information in departmental, operations, and client meetings • Work in office, laboratory, and/or clinical environments • Use required personal protective equipment and handle potential exposure to biological fluids and infectious organisms

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 2+ years of previous QA experience • Thorough knowledge of GCP and appropriate regional research regulations and guidelines • Demonstrated proficiency in project-based or internal GCP audits and vendor audits • Excellent oral and written communication skills • Strong problem-solving, risk assessment, and impact analysis abilities • Experience in root cause analysis • Negotiation and conflict management skills • Ability to multitask and prioritize competing demands/workload • Valid driver's license • Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel • Ability to work in an upright and/or stationary position for 6–8 hours per day • Ability to perform frequent mobility, bending, twisting, crouching, and stooping • Ability to lift and carry 15–20 lbs • Ability to access and use computer software • Regular and consistent attendance

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Commitment to scientific excellence

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