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
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