QA Clinical Auditor II

đŸ”„ 15 minutes ago

đŸ‡§đŸ‡· Brazil – Remote

⏰ Full Time

🟱 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 15 minutes ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

đŸ„ Healthcare

Biotechnology ‱ Pharmaceuticals ‱ Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

‱ Conduct and/or lead client, internal, GCP audits and regulatory inspections ‱ Perform directed site, facility, vendor and subcontractor audits ‱ Provide GCP consultation and support to project teams and external clients ‱ Lead process audits and participate as a co-auditor in complex system audits ‱ Perform QA audits and 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 at departmental, internal operations and client meetings ‱ Work in office/laboratory and/or clinical environments ‱ Follow required personal protective equipment and physical/attendance requirements

🎯 Requirements

‱ Bachelor's degree or equivalent and relevant formal academic / vocational qualification ‱ 2+ years of previous QA experience ‱ Knowledge of GCP and appropriate regional research regulations and guidelines ‱ Proficiency leading 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 access and use in-house and off-the-shelf computer software ‱ Regular and consistent attendance

đŸ–ïž Benefits

‱ Global team environment ‱ Collaboration and development opportunities ‱ Scientific excellence-focused workplace

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