QA Auditor II

🔥 11 minutes ago

🌐 United Kingdom, France, +1 more countries – Remote

infoinfo

⏰ 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 11 minutes ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 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, facility, vendor, subcontractor and regulatory inspection audits • Perform directed site audits and other QA audits or activities, including database audits, clinical study report audits, sample results tables and process improvement • Provide GCP consultation and support to project teams and external clients • Participate as a co-auditor in complex system audits • Serve as a QA and audit subject-matter resource for operational departments • Prepare and present audit findings and related information at departmental, internal operations and client meetings • Enhance clinical auditing processes and ensure regulatory compliance and quality standards • Work with biological fluids, potentially infectious organisms and electrical office equipment in office, laboratory and clinical environments • Communicate and collaborate with diverse groups while managing variable tasks and changing conditions

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • Previous QA experience comparable to 2+ years • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Thorough knowledge of GCP and appropriate regional research regulations and guidelines • Demonstrated proficiency leading project-based or internal audits and vendor audits • Excellent oral and written communication skills • Strong problem-solving, risk assessment and impact analysis abilities • Solid experience in root cause analysis • Above-average 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 office/laboratory and/or clinical environments • Ability to use required personal protective equipment • Ability to work upright and/or stationary for 6–8 hours per day • Ability to perform repetitive hand movements and frequent mobility • Ability to lift and carry 15–20 lbs • Ability to access and use in-house and off-the-shelf computer software • Regular and consistent attendance

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Collaboration and development opportunities • Exposure to a global team environment • Corporate credit card with sufficient credit line for business travel

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