Quality Auditor II

Position: Quality Auditor II
Salary: $75,000-$85,000
Benefits: Medical, Dental, 401k match, PTO
Location: Muskegon, MI | Onsite

Overview of the Quality Auditor II Position: 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 of the Quality Auditor II:

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

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• 5+ years of Quality Assurance experience supporting GLP-regulated studies and laboratory environments.
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• Strong knowledge of FDA, OECD, and GLP regulations and quality system requirements.
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• Experience conducting protocol, report, process, and facility audits.
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• Experience reviewing laboratory data, study documentation, and quality records.
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• Strong technical writing and audit reporting skills.
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• Understanding of laboratory operations, study conduct, and research workflows.
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• Excellent communication and stakeholder management abilities.
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• Ability to manage multiple priorities, projects, and deadlines in a regulated environment.
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• Strong analytical, critical-thinking, and problem-solving skills.
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• Bachelor's degree in a scientific discipline or related field preferred.
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Bonus Experience of the Quality Auditor II:

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• Computer System Validation (CSV) experience.
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• Experience supporting 21 CFR Part 11 compliance initiatives.
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• RQAP certification through the Society of Quality Assurance (SQA).
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• Lead auditor experience supporting multi-site studies.
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• Experience participating in regulatory inspections and agency interactions.
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• CAPA leadership and quality improvement program experience.
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• Archive management and records retention experience.
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• Experience within CRO, biotechnology, pharmaceutical, or research laboratory environments.
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Why Join This Opportunity?

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• Play a key role in maintaining quality and compliance across critical research and laboratory operations.
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• Work closely with scientific, operational, and executive leadership teams.
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• Influence quality systems, regulatory readiness, and continuous improvement initiatives.
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• Gain exposure to Computer System Validation, supplier audits, regulatory inspections, and multi-site study oversight.
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• Join an organization committed to quality, compliance, and professional growth.
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• Opportunity to make a meaningful impact on product quality, regulatory success, and organizational performance.
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