Senior QA Specialist

Job Description

• 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

Qualifications

• 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
  • Audit hosting (client and/or regulatory)
  • Quality systems (change control, deviations, document control)
  • 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

Additional Information

Position is full time, Monday to Friday, 8AM - 5PM. Candidates currently living within a commutable distance of Portage, MI are encouraged to apply.

Excellent full time benefits including

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.