Quality Auditor

CFS; 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

CFS in Muskegon, MI is seeking a Senior Quality Auditor to ensure GLP compliance across studies, protocols, and facility processes. You will audit protocols, studies, reports, and CAPA plans, supporting regulatory inspections and quality systems.

This onsite role emphasizes collaboration with leadership to strengthen quality across sites. The position requires 5+ years in QA within GLP-regulated environments, plus strong knowledge of FDA and OECD regulations, with excellent report writing and

Qualifications

• 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.
• Bonus: Computer System Validation (CSV) experience and 21 CFR Part 11 compliance.

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.

Skills

QA experience

GLP knowledge

FDA regulations

OECD regulations

Protocol audits

Report audits

Data review

Technical writing

Stakeholder management

Multi-site audits

CAPA leadership

CSV experience

21 CFR Part 11

Regulatory inspections

Archive management

Education

Bachelor's degree in a science-related discipline

Job description

Position:

Quality Auditor

Salary:

$55,000 - 80,000 + Bonus Potential

Benefits:

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

Location:

Muskegon, MI (Onsite)

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.

Responsibilities Of The Quality Auditor

• 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.

Preferred Experience Of The Quality Auditor

• 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.
• Bonus Experience of the Quality Auditor
• 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.

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