Clinical Auditor III – GCP

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🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $75k - $115k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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

• Lead complex internal and external audits to ensure compliance with quality assurance processes, standards, global regulatory guidelines, and client contractual requirements • Identify quality and regulatory compliance issues, assess root causes of non-conformance, and develop risk-mitigation strategies • Conduct technical document reviews and other Good Clinical Practice activities supporting clinical projects and company processes • Conduct and/or lead client, internal, GCP, clinical site, facility, process, database, clinical study report, and vendor audits • Support regulatory inspections and participate as a co-auditor on complex system audits • Provide GCP consultation and quality support to project teams and external clients • Conduct sample results table reviews and process-improvement initiatives • Serve as a subject matter resource to operational teams on audit and quality assurance topics • Prepare, communicate, and present audit findings and quality-related information at departmental, internal operations, and client meetings • Provide mentorship, guidance, and subject matter support to junior auditors

🎯 Requirements

• Bachelor's degree or equivalent relevant formal academic or vocational qualification • 5+ years of previous Quality Assurance experience • Audit experience in a regulated industry; clinical research or pharmaceutical experience highly preferred • Detailed knowledge of Good Clinical Practice (GCP) and applicable regional clinical research regulations and guidelines • Experience leading project-based and/or internal GCP audits and vendor audits • Excellent written and verbal communication skills • Strong problem-solving, risk-assessment, and impact-analysis capabilities • Experience conducting root cause analysis • Strong negotiation and conflict-management skills • Ability to work effectively in a dynamic environment, manage multiple priorities, and balance competing demands and workloads • Ability to travel as required, up to 50% within the US and possibly internationally • Valid driver's license and ability to meet company requirements for business travel • Ability to communicate, receive, and understand information and ideas with diverse groups of people • Ability to work upright and stationary for typical working hours • Ability to use and learn standard office equipment and technology proficiently • Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities • Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, including drug screening

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results in accordance with company policy • Reasonable accommodation for individuals with disabilities • Opportunities for experience and growth • Relocation assistance is NOT provided