Job Title: QA Auditor
Category: Regulatory / Compliance
Location: Madison, Wisconsin, USA
Job ID: 2536964
Job Type: Full-Time
Remote: No
Company Overview
LabCorp is a leading provider of clinical laboratory testing and drug development support. The Quality department ensures compliance with regulatory standards and internal SOPs, maintaining integrity and excellence across laboratory operations.
Role Overview
The QA Auditor in Madison, WI, audits Immunology and Immunotoxicology work to ensure compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP, 21 CFR Part 58). This role involves study protocol, data, report, and in-lab phase audits, SOP peer review, and supporting internal inspections.
Key Responsibilities
Conduct protocol reviews, report/data audits, and internal facility/process inspections
Peer review QA SOPs
Represent QA in operational liaison meetings
Report relevant quality metrics and highlight trends
Ensure compliance with regulatory and quality assurance standards per controlled documents
Education & Experience Requirements
Education:
Bachelor’s Degree in Life Sciences preferred (or equivalent experience)
Experience may be substituted for education
Experience:
Minimum 2 years in a regulatory environment
Knowledge of and ability to interpret applicable regulations to monitor compliance
Experience with plate reading technologies (e.g., MesoScale, EliSpot, BioPlex)
Understanding of cell viability, cell potency testing, and basic principles of flow cytometry
Ability to interpret data and identify quality-critical issues
Able to communicate regulatory expectations effectively
Skills & Competencies
Strong analytical and problem-solving abilities
Attention to detail and organizational skills
Effective written and verbal communication
Benefits
Employees working ≥20 hours/week are eligible for:
Medical, Dental, Vision, Life, STD/LTD coverage
401(k) plan
Paid Time Off (PTO) / Flexible Time Off (FTO)
Tuition Reimbursement
Employee Stock Purchase Plan
Casual, PRN, and part-time employees (<20 hours/week) are eligible for 401(k) only.
Equal Opportunity Employer Statement
LabCorp is committed to inclusion and belonging and prohibits harassment or discrimination. Employment decisions are based on qualifications, merit, and business needs. Qualified applicants are considered regardless of:
Race, religion, color, national origin, sex, pregnancy/childbirth, family/parental status, marital/civil union status, sexual orientation, gender identity/expression, appearance, age, veteran status, disability, genetic information, or other legally protected characteristics
Arrest or conviction records (per applicable law)
Accessibility: Individuals with disabilities needing assistance can contact LabCorp Accessibility.
How to Apply
Apply online via LabCorp careers site
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