Senior GLP Quality Auditor — Lead Multi-Site QA (Onsite)

Creative Financial Staffing, LLC; Grand Haven (MI); On-site; USD 55,000 - 80,000; Full time

Benefits offered by this job

Medical

Dental

401(k)

PTO

Professional Development

Job summary

Creative Financial Staffing, LLC seeks a Quality Auditor to ensure GLP-compliant QA across laboratory studies, protocols, reports, and facility processes. You will support regulatory inspections, CAPA initiatives, and Computer System Validation, contributing to continuous improvement and strong quality systems.

The ideal candidate brings 5+ years of QA experience in GLP settings, familiarity with FDA/OECD regulations, and solid audit skills.

Qualifications

• 5+ years of QA experience in GLP-regulated environments.
• Strong knowledge of FDA, OECD, and GLP regulations.
• Experience conducting protocol, report, and facility audits.
• Strong technical report writing skills.
• Ability to manage multiple priorities and deadlines.

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 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.

Skills

QA experience

GLP compliance

Regulatory knowledge

Audit skills

Communication

Education

Bachelor's degree in science

Job description

Creative Financial Staffing, LLC seeks a Quality Auditor to ensure GLP-compliant QA across laboratory studies, protocols, reports, and facility processes. You will support regulatory inspections, CAPA initiatives, and Computer System Validation, contributing to continuous improvement and strong quality systems.

The ideal candidate brings 5+ years of QA experience in GLP settings, familiarity with FDA/OECD regulations, and solid audit skills.