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Qa Auditor

2+ years
Not Disclosed
10 Nov. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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