Job Description

Title: Senior QA Compliance Auditor

Location: Indianapolis, IN 46214

Duration: 6 Months (Contract-to-Hire)

Shift Timing: 1st Shift | 8:00 AM to 5:00 PM Mon-Fri

Payrate: $40.86/hr

Job Summary:

• We are seeking a highly skilled, experienced Senior QA Compliance Auditor to join our team on a contract-to-hire basis.
• 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.

Key Responsibilities:

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.

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.

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.

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.

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)

Additional Information:

• Travel: Occasional regional travel (5%) may be required.

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