Senior QA Specialist

Eurofins • Portage, MI

2d • Onsite

About The Position

Eurofins Scientific is an international life sciences company providing analytical testing services. The Senior QA Specialist will lead and perform deviation and investigation writing/review, including root cause analysis and CAPA development. This role involves reviewing and approving quality agreements, hosting and supporting external audits, and conducting internal audits. The specialist will also perform risk assessments, drive data integrity compliance, manage change control processes, and review/approve SOPs, analytical methods, protocols, and reports. Additionally, the role includes releasing analytical reports, contributing to quality metrics reporting, identifying continuous improvement opportunities, and partnering cross-functionally to ensure quality objectives are met. A strong commitment to safe, compliant, and efficient operations is essential.

Requirements

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or related scientific discipline
• 4+ years of QA experience within a pharmaceutical or regulated laboratory environment
• Proven experience with investigations and CAPA management
• Proven experience with audit hosting (client and/or regulatory)
• Proven experience with quality systems (change control, deviations, document control)
• Proven experience with data integrity principles and compliance expectations
• Strong working knowledge of GxP (GMP/GLP) regulations
• Excellent written and verbal communication skills
• Ability to confidently interact with clients, auditors, and internal stakeholders
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)
• Authorization to work in the U.S. without sponsorship

Responsibilities

• Lead and perform deviation and investigation writing/review, including thorough root cause analysis and CAPA development/effectiveness checks
• Review and approve quality agreements and ensure alignment with regulatory and client requirements
• Host and support external audits, including regulatory agency inspections and client audits
• Conduct internal audits, walkthrough inspections, and ensure audit readiness across laboratory operations
• Perform and support risk assessments to proactively identify and mitigate quality risks
• Drive data integrity compliance initiatives, ensuring adherence to ALCOA+ principles
• Manage and support change control processes, ensuring impact assessments and compliance with procedures
• Review and approve SOPs, analytical methods, protocols, and reports
• Release and ensure accuracy of analytical reports
• Contribute to monthly and quarterly quality metrics reporting
• Identify and implement continuous improvement opportunities within QA and laboratory functions
• Partner cross-functionally with laboratory staff, clients, and leadership to ensure quality objectives are met
• Maintain a strong commitment to safe, compliant, and efficient operations

Benefits

• Comprehensive medical coverage
• Dental options
• Vision options
• Life insurance
• Disability insurance
• 401(k) with company match
• Paid vacation
• Paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior