Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
10,000+
QA Auditor II
September 20
Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
10,000+
Description
• Conducts complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. • Identifies issues impacting quality and/or regulatory compliance, supports determination of root cause of non-conformance and assists in developing strategies to address issues. • May perform technical document review and other GxP activities in support of project work or company process. • Provides finished audit reports to management. • Plans and delivers billable quality services for clients and projects • Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management • Performs directed site audits, facility, vendor and/or sub-contractor audits • Provides GxP consultation and support to project teams and external clients • Leads process audits and may participate as a co-auditor in more complex system audits • Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
Requirements
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) • GCP/Auditing Experience • Experience working in GCP Environment • Auditing experience • 25% travel required internationally
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