Staff Specialist - Quality Auditor

November 13

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Ensure compliance with global governmental regulatory requirements and corporate policies for Controlled Substances • Conduct audits, gap assessments, and evaluate the state of quality and regulatory compliance • Identify compliance gaps and assess quality adherence • Perform audit-related tasks (scheduling, reviewing documentation, providing feedback) • Monitor and confirm the effectiveness of corrective actions • Analyze audit data and recommend risk mitigation strategies • Develop and deliver auditor training materials for internal quality auditors • Participate with quality and management teams to drive continual improvement

Requirements

• Bachelor of Science (B.Sc.) in chemistry, biology, pharmacy, or related fields • Minimum ten years of quality management systems work experience in a regulated industry • Minimum three years of practical auditing experience in certified quality management systems • Three years of (R&D, manufacturing, and/or testing) work experience in controlled substances • Experience in quality management-related activities within controlled substances • Expert level knowledge of controlled substance regulations (e.g., US FDA CFR, Health Canada) • Experience with quality and regulatory methods and techniques, including auditing • Strong oral and written communication, presentation, and technical writing skills (English) • Ability to conduct remote auditing, when required • Lead Auditor certification preferred • Ability to travel 30-40% within the Continental US and internationally

Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits