Senior QA Compliance Auditor

Lead CLIA QA Compliance Auditor

Join a leading central laboratory that provides testing and bioanalysis services as a Lead QA Compliance Auditor (CLIA / CAP) within the Quality Assurance team. This role focuses on ensuring that the organization's operations and procedures meet both government and industry compliance standards. A compliance analyst may research regulations and policies, communicate requirements, and apply for compliance certifications on behalf of the organization.

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.

Qualifications

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).

Essential Skills

Quality Assurance, Audit, CLIA / CAP, Regulatory Compliance, GXP, ISO Certified Auditor, Risk Management, Internal Audit, External Audit, Corrective and Preventative Actions (CAPA), Laboratory Reports, Continuous Improvement Analyst Certification (CQI), Root Cause Analysis, ISO 13485, Compliance, QA Audit.

How To Apply

Interview availability this week only. I am scheduling interviews for this position and conducting phone interviews as early as TODAY. All candidates will be considered immediately within 24 hours of reaching out and applying directly to Grace Williams.

HOW TO APPLY DIRECTLY : Email your updated resume, brief intro about your interest, preferred method of communication for you (i.e., call, email, text) to grawilliams@actalentservices.com and / or CALL / TEXT ME : 317 567 6610

Pay and Benefits

The 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 :

Workplace Type

This is a fully onsite position in Indianapolis, IN.

Application Deadline

This position is anticipated to close on Nov 6, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.