Description
\t\t\t\t\tIn February 2015, LabCorp purchased Covance Drug Development for $6 billion, which immediately made LabCorp the world’s leading health care diagnostics and drug development company. This local facility is their central laboratory for testing services and bioanalysis services. Currently their Quality Assurance team is actively seeking a new Senior QA Auditor to join their group long-term.Summary: This role supports clinical research drug development, offering commercial diagnostic laboratory testing services within a highly regulated setting. The ideal candidate will bring deep expertise with an action-oriented mindset and the ability to lead challenging audit activities across the global enterprise to ensure operational compliance to GCP, GCLP, ISO 13485, ISO 15189, CAP/CLIA regulations and industry standards.Job Responsibilities: 1) Audit Planning, Execution & Oversight • Plan, schedule, and conduct audits across the clinical laboratory, and operational support functions. • Host and support sponsor-client audits and regulatory inspections • Perform external audits of suppliers and service providers. • Support audit response development and CAPA implementation, ensuring responsiveness and delivery requirements are met for client and business stakeholders.2) Compliance Monitoring & Issue Resolution • Evaluate adherence to SOPs, regulatory requirements, and industry standards. • Lead the response process for audits and inspections, including CAPA development, implementation and tracking. • Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness. • Support global QA policy implementation and interpretation of regulatory requirements. • Ensure compliance with applicable regulations (GCP, ISO 15189, CAP, etc.) and internal quality standards. • Participate in global quality initiatives to improve compliance and operational efficiency.3) Training & Continuous Improvement • Develop, deliver and participate in training on audit practices and compliance expectations. • Promote a culture of quality and continuous improvement across teams.4) Documentation & Reporting • Prepare detailed audit reports with actionable recommendations. • Track and report quality metrics, identifying trends and areas for improvement. • Maintain audit records and ensure inspection readiness.Essential Job Duties:- Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)- Contributes to global QA policies on interpretation/ application of regulations- Provide subject matter expertise to projects Support team in CAPA plan creation- Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses- Supports the QA–to-QA relationship with key client(s)- Delivery of training in performance of audits (basic, intermediate, complex)- Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization- Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed- Other duties as assigned by management.
\t\t\t\t\t\t\t\t\t\tSkills
\t\t\t\t\tQuality Assurance, Audit, auditors, quality control, drug development, internal control, fda, capa, auditing, clinical laboratory, clinical laboratory testing, microbiological, lab documentation, laboratory, Risk Management, GXP, GMP, GLP, ISO 13485, Regulatory, Regulatory Audit, Certified Auditor, Internal Audit, External Audit, Compliance, QA Audit, sop, batch record, pharma, pharmaceutical, clinical lab, CLIA, regulatory compliance, fda compliance, external auditing, gcms, chemistry, biological science, lab auditing
\t\t\t\t\t\t\t\t\t\tTop Skills Details
\t\t\t\t\tQuality Assurance,Audit,auditors,quality control,drug development,internal control,fda,capa,auditing,clinical laboratory,clinical laboratory testing,microbiological,lab documentation,laboratory
\t\t\t\t\t\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\tQualifications• Education: Bachelor’s degree in life sciences or related field; advanced degree preferred. - Equivalent experience may be considered in lieu of advanced education requirements .• Experience: - Minimum 6 years in a regulatory or GxP-compliant environment. - Proven experience with quality systems and regulatory inspections. - Strong understanding of ISO 15189, ISO 13485, and risk-based auditing methodologies.• Skills: - Strong communication, organizational, negotiation, and problem-solving skills. - Ability to influence cross-functional teams and drive compliance initiatives. - Success-oriented in working both independently and in dynamic team environments. - Proficiency with quality management system applications and/or platforms (e.g., Veeva, TrackWise) is a plus.• Certifications (Preferred): - ASQ Certified Quality Auditor (CQA) - ASQ Certified Quality Manager or Quality Engineer (CQM/CQE)- - SQA Registered Quality Assurance Professional (RQAP)
\t\t\t\t\t\t\t\t\t\tExperience Level
\t\t\t\t\tExpert Level
\t\t\t\t\tJob Type & LocationThis is a Contract to Hire position based out of Indianapolis, IN.
Pay and BenefitsThe pay range for this position is $40.86 - $41.10/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace TypeThis is a fully onsite position in Indianapolis,IN.
Application DeadlineThis position is anticipated to close on Feb 9, 2026.
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