Overview
Pre-clinical GLP QA Auditor Jobs in Muskegon, Michigan, USA at Medix™
Position: Pre-clinical GLP QA Auditor – Job ID: 240819
Pre-clinical GLP QA Auditor – Job
6 days ago Be among the first 25 applicants
This range is provided by Medix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$70,000.00/yr – $85,000.00/yr
GLP Quality Assurance Auditor – Growing Biotech Organization
Location: Muskegon, MI (On-Site)
Competitive Salary + 15% Performance-Based Bonus
Are you an experienced GLP QA Auditor looking to make an impact in a rapidly growing organization? We are hiring a Quality Assurance Auditor to support GLP pre-clinical studies at our brand-new, state-of-the-art facility that opened in 2025.
This is an exciting opportunity to lead quality initiatives, drive compliance, and contribute to process improvements in a cutting-edge environment. If you have a strong background in GLP auditing, regulatory compliance, and CAPA management, we want to hear from you!
Key Responsibilities
Ensure GLP studies align with all protocol-specified regulations and proper documentation is maintained.
Audit protocols, amendments, in-process phases, and final study reports for GLP and Method Validation Studies.
Act as Lead QA Auditor in multi-site studies.
Maintain the Master Schedule and conduct Annual Facility Audits & Process-Based Audits.
Review Standard Operating Procedures (SOPs) and provide regulatory training as needed.
Host and interact with regulatory agencies and auditors during inspections and audits.
Assist in supplier qualifications via remote or off-site inspections.
Track and trend deviations and audit findings.
Lead or consult on process improvement and CAPA projects.
Support Computer System Validation (CSV) reviews and consultations.
Serve as backup archivist as needed.
Qualifications
Bachelor’s Degree in Animal or Life Sciences (or related discipline).
3+ years of experience as a QA Auditor in a GLP pre-clinical setting.
Strong experience with CAPAs, root cause analysis, and compliance audits.
Excellent communication skills with experience collaborating across teams.
Detail-oriented with strong problem-solving abilities.
Nice to Have
Experience as a Project Manager or Scientist.
Prior experience hosting sponsor visits and regulatory inspections.
Why Join Us?
Be part of a growing organization with exciting expansion plans.
Work in a brand-new, cutting-edge facility designed for innovation.
15% annual bonus based on company performance (with potential for higher earnings).
Opportunity to lead QA initiatives and work on high-impact projects.
Hiring Now! Don’t miss this chance to advance your career in a forward-thinking organization that values quality, compliance, and professional growth.
Seniority level
Associate
Employment type
Full-time
Job function
Science, Research, and Quality Assurance
Industries
Biotechnology Research and Research Services
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Title: Pre-clinical GLP QA Auditor
Company: Medix™
Location: Muskegon, Michigan, USA
Category: Quality Assurance – QA/QC (QA Specialist / Manager)
