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Qa Auditor - Toxicology

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 – Toxicology

Category: Regulatory / Compliance
Location: Greenfield, Indiana, USA
Job ID: 2536753
Job Type: Full-Time
Remote: No


Company Overview

LabCorp is a global leader in laboratory services, supporting drug development and clinical research with a focus on compliance, quality, and scientific integrity. This role is within the early development toxicology team, supporting pre-clinical studies.

  • Focus Areas: Dose formulation, dose analysis, animal operations, clinical pathology, anatomic pathology

  • Culture: Collaboration with clients to ensure compliance and quality in pre-clinical research


Role Overview

The QA Auditor – Toxicology ensures compliance with Good Laboratory Practices (GLP) and company SOPs. The role involves auditing pre-clinical studies, reviewing protocols and data, supporting inspections, and providing training on quality standards.

  • Location: Greenfield, IN (on-site, not remote)

  • Visa Sponsorship: Not eligible


Key Responsibilities

Auditing & Compliance

  • Conduct protocol reviews, report/data audits, and internal facility/process inspections

  • Evaluate responses to inspection reports and ensure proper resolution

  • Peer review QA SOPs

  • Support operational liaison meetings representing QA function

  • Report on relevant quality metrics and highlight trends

  • Ensure adherence to Regulatory Compliance and Quality Assurance responsibilities (GCP, GMP, GLP)

Training & Support

  • Provide training on SOPs, compliance requirements, and audit processes

  • Communicate regulatory expectations clearly to operations and staff

Process Improvement

  • Influence process improvement initiatives and provide solutions

  • Apply critical thinking to identify quality-critical problems and opportunities for enhancement


Minimum Education & Experience Requirements

  • Bachelor’s Degree in Life Sciences preferred (or equivalent experience)

  • Minimum 2 years of experience in a GLP regulatory environment (more GLP experience is a plus)

  • Knowledge of industry quality systems and regulations to monitor compliance

  • Experience as a GxP auditor

  • Ability to interpret data and identify quality-critical issues

  • Clear communication and ability to convey regulatory expectations

Preferred Qualifications

  • Experience in process improvement and quality auditing

  • Experience in FDA 21 CFR Part 58 environment

  • Ability to provide clear feedback and articulate processes for training


Benefits

Employees scheduled to work ≥20 hours/week are eligible for:

  • Medical, Dental, Vision, Life, STD/LTD coverage

  • 401(k) plan

  • Paid Time Off (PTO) or Flexible Time Off (FTO)

  • Tuition Reimbursement

  • Employee Stock Purchase Plan

Casual, PRN, or part-time employees (<20 hours/week) are eligible for the 401(k) plan 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, family/parental status, marital status, sexual orientation, gender identity/expression, appearance, age, veteran status, disability, genetic information, or other legally protected characteristics

  • Arrest or conviction records (considered per applicable law)

Accessibility: Individuals with disabilities needing assistance to search or apply online can contact LabCorp Accessibility.


How to Apply

  • Apply online via LabCorp careers site