QA Auditor I

Quality Assurance Auditor position at Thermo Fisher Scientific's GMP laboratory in Middleton, Wisconsin. The role involves conducting routine audits of laboratory project data and documentation, ensuring compliance with regulatory requirements, and supporting laboratory teams to maintain data integrity and quality standards.

Responsibilities

• Conduct routine QA audits of GMP laboratory project data and associated documentation
• Review project data for compliance with GMP requirements, approved procedures, and protocols
• Document audit observations and communicate findings to laboratory personnel and stakeholders
• Perform facility inspections to assess compliance with GMP requirements and quality standards
• Support quality improvement initiatives that enhance compliance and operational efficiency

Requirements

• Bachelor's degree or equivalent; Associates degree with relevant experience acceptable
• 1 year or more of laboratory or quality assurance experience
• Introductory knowledge of GMP requirements and regulatory expectations
• Strong attention to detail with focus on data accuracy and integrity
• Effective written and verbal communication skills with scientific terminology
• Analytical and problem-solving abilities with strong organizational skills
• Basic computer proficiency and ability to learn quality management systems