Quality Auditor

About the role

Overview Of The Quality Auditor Position The Senior Quality Auditor ensures compliance with GLP regulations and quality standards across laboratory operations, study execution, and quality systems. This role conducts audits of protocols, studies, reports, and facility processes while supporting regulatory inspections, computer system validation, CAPA initiatives, and continuous improvement efforts. Location: Muskegon, MI (Onsite).

Responsibilities

• Conduct in-process audits of laboratory studies and operations.
• Audit protocols, amendments, raw data, and final reports.
• Lead QA activities for multi-site studies.
• Perform process-based audits and facility inspections.
• Maintain and monitor the QA Master Schedule.
• Review SOPs, equipment qualifications, and quality documentation.
• Represent QA during sponsor and regulatory inspections.
• Lead or support Computer System Validation and 21 CFR Part 11 compliance audits.
• Support supplier qualification audits.
• Track and trend deviations and audit findings.
• Lead CAPA and process improvement initiatives.
• Train employees on GLP and quality requirements.
• Serve as backup Archivist when needed.
• Support annual facility audits and inspection readiness.
• Partner with leadership to strengthen quality systems.

Requirements

• 5+ years of QA experience supporting GLP-regulated studies.
• Strong knowledge of FDA, OECD, and GLP regulations.
• Experience conducting protocol, report, and facility audits.
• Experience reviewing laboratory data and documentation.
• Strong technical report writing skills.
• Understanding of laboratory operations and study conduct.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities and deadlines.
• Strong analytical and critical-thinking skills.
• Bachelor's degree in a science-related discipline preferred.
• Computer System Validation (CSV) experience.
• 21 CFR Part 11 compliance experience.
• RQAP certification from SQA.
• Lead auditor experience on multi-site studies.
• Regulatory inspection experience.
• CAPA leadership experience.
• Archive management experience.
• CRO, biotechnology, pharmaceutical, or research laboratory experience.

Benefits

• Medical
• Dental
• 401(k)
• PTO
• Professional Development

Pay

Salary: $55,000 - 80,000 + Bonus Potential