Quality Auditor II

Location: Muskegon, MI (Onsite)

About the role

The Quality Auditor II plays a critical role in ensuring compliance with Good Laboratory Practice (GLP) regulations and maintaining the integrity of quality systems across laboratory and research operations. This position is responsible for conducting audits of studies, protocols, reports, facilities, and processes while partnering with laboratory leadership to strengthen compliance, inspection readiness, and continuous improvement initiatives. The ideal candidate brings a strong understanding of GLP-regulated environments, enjoys identifying opportunities for process improvement, and has experience supporting regulatory inspections, CAPA programs, and quality system enhancements. This role offers the opportunity to influence quality culture, support strategic initiatives, and work closely with scientific, operational, and regulatory stakeholders.

Responsibilities

• Conduct in-process audits of laboratory studies and operational activities.
• Review and audit protocols, amendments, raw data, and final study reports for compliance.
• Lead Quality Assurance activities supporting multi-site studies.
• Perform facility inspections and process-based audits across laboratory operations.
• Maintain and oversee the Quality Assurance Master Schedule.
• Review SOPs, equipment qualification records, and quality documentation.
• Represent Quality Assurance during sponsor audits and regulatory inspections.
• Lead or support Computer System Validation (CSV) initiatives and 21 CFR Part 11 compliance activities.
• Participate in supplier qualification and vendor audits.
• Track, trend, and report audit findings, deviations, and quality metrics.
• Lead CAPA investigations and continuous improvement efforts.
• Train and mentor employees on GLP requirements and quality best practices.
• Serve as backup Archivist and support document retention activities as needed.
• Support annual facility audits and overall inspection readiness programs.
• Partner with leadership to strengthen quality systems and regulatory compliance.

Requirements

• 5+ years of Quality Assurance experience supporting GLP-regulated studies and laboratory environments.
• Strong knowledge of FDA, OECD, and GLP regulations and quality system requirements.
• Experience conducting protocol, report, process, and facility audits.
• Experience reviewing laboratory data, study documentation, and quality records.
• Strong technical writing and audit reporting skills.
• Understanding of laboratory operations, study conduct, and research workflows.
• Excellent communication