QA Auditor II

🔥 12 hours ago

🌐 United Kingdom, France, +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, directed site, facility, vendor, and subcontractor audits and regulatory inspections • Provide GCP consultation and support to project teams and external clients • Participate as a co-auditor in complex system audits • Perform QA activities including database audits, clinical study report audits, sample results table audits, 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 • Handle potential exposure to biological fluids, infectious organisms, and electrical office equipment while using required personal protective equipment • Work with varied demands, changing conditions, physical activity, and frequent interactions with diverse groups

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 2+ years of previous QA experience • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered sufficient • Thorough knowledge of GCP and appropriate regional research regulations and guidelines • 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 • 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

🏖️ Benefits

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

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