GCP QA Auditor III

🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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This company has sponsored H1B visas in the past.

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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 and/or multi-department internal and external audits • Ensure compliance with quality assurance processes, standards, global regulatory guidelines and client contractual obligations • Identify quality and regulatory compliance issues and determine root causes of non-conformance • Develop strategies to address quality and compliance issues • Perform technical document reviews and other GCP activities • Conduct or lead client, internal and GCP audits and regulatory inspections • Lead site, facility, vendor and subcontractor audits • Provide GCP consultation and support to project teams and external clients • Lead process audits and participate as co-auditor in complex system audits • Perform database audits, clinical study report audits, sample results table audits and process improvement activities • Serve as a quality assurance resource to operational departments • Prepare and present audit findings at departmental, internal operations and client meetings • Provide mentorship and guidance to junior auditors • Prepare finished audit reports for management • Plan and deliver billable quality services for clients and projects • Serve as a client contact when needed

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous GCP QA experience comparable to 5+ years • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Detailed 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 • 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

🏖️ Benefits

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

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