GLP Quality Auditor II — Compliance & CAPA Lead

CFS; Spring Lake (MI); Presencial; USD 75 000 - 85 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical

Dental

401k match

PTO

Resumo da oferta

CFS is seeking a Quality Auditor II to uphold GLP compliance across laboratory operations. The role conducts audits of studies, protocols, and facilities, partnering with leadership to drive inspection readiness and continuous improvement.

The ideal candidate has 5+ years in QA within GLP-regulated settings, strong regulatory knowledge (FDA/OECD), and excellent audit reporting and stakeholder management skills. Onsite in Muskegon, MI.

Qualificações

• 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 analytical, writing, and communication skills.

Responsabilidades

• Conduct in-process audits of laboratory studies and operational activities.
• Review and audit protocols, amendments, raw data, and final study reports for compliance.
• Lead QA 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 QA during sponsor audits and regulatory inspections.
• Lead or support 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.

Conhecimentos

Quality Assurance

Regulatory knowledge

Audit reporting

Stakeholder management

GLP understanding

Formação académica

Bachelor's degree in a scientific discipline

Descrição da oferta de emprego

CFS is seeking a Quality Auditor II to uphold GLP compliance across laboratory operations. The role conducts audits of studies, protocols, and facilities, partnering with leadership to drive inspection readiness and continuous improvement.

The ideal candidate has 5+ years in QA within GLP-regulated settings, strong regulatory knowledge (FDA/OECD), and excellent audit reporting and stakeholder management skills. Onsite in Muskegon, MI.