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Compliance Auditor

8+ 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: Compliance Auditor

Category: Regulatory / Compliance
Location: Indianapolis, Indiana, USA
Job ID: 2533058
Job Type: Full-Time
Remote: No (Onsite at 8211 Scicor Drive, Indianapolis, IN)


Company Overview

LabCorp is a leading pharmaceutical solutions company, delivering clinical laboratory testing, drug development support, and compliance solutions. The Quality team ensures operational excellence, regulatory compliance, and continuous improvement across laboratory testing and operational environments.


Role Overview

The Compliance Auditor ensures clinical research laboratories comply with global regulatory standards and industry best practices, including:

  • GCP/GLP

  • ISO 15189

  • ISO 13485

The role leads the internal audit program, mentors junior auditors, drives process improvements, and collaborates with management and cross-functional teams to maintain regulatory integrity.


Key Responsibilities

Internal Audit Program Management

  • Plan, schedule, and implement the internal audit program

  • Develop audit scopes to ensure comprehensive assessments

  • Assign audits to team members and oversee execution

Preparedness & Oversight

  • Engage stakeholders throughout the audit process

  • Facilitate planning and communication with relevant parties

Audit Hosting & Regulatory Support

  • Host internal audits and provide regulatory inspection support

  • Assist with sponsor audits as required

Audit Reporting & Follow-Up

  • Document findings and develop actionable audit reports

  • Lead audit review meetings and collaborate on CAPA implementation

  • Monitor effectiveness of corrective actions

Audit Program Monitoring

  • Lead monthly audit meetings and monitor audit activities

  • Ensure audit and inspection readiness aligned with CLS QA programs

Internal Auditor Development

  • Train and mentor internal auditors

  • Ensure regulatory updates are integrated into staff training and team activities

  • Develop audit leads and promote continuous professional development

QA Project Support

  • Support and participate in QA projects to uphold compliance and continuous improvement


Preferred Skills & Qualifications

  • Strong written and verbal communication skills

  • Excellent organizational and project management skills

  • Experience in risk management and risk-based auditing

  • Experience in training and developing internal auditors

  • Laboratory/quality background with ISO 15189/ISO 13485 knowledge

  • Experience with compliance software (e.g., Veeva, Trackwise)

Recommended Certifications

  • ASQ Quality Auditor Certification

  • ASQ Quality Manager Certification

  • ASQ Quality Engineer Certification


Education & Experience Requirements

  • Education: Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field (Postgraduate degree preferred)

  • Experience:

    • Minimum 8 years in a regulatory environment (GxP roles)

    • Regulatory expertise in multiple regulations

    • Lead auditor experience and ability to communicate strategically with clients

    • Experience leading process improvement initiatives


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