Actalent
Job Title
HIRING NOW: SR. QA Compliance Auditor
Location Indianapolis, IN
Immediate Hiring Join a leading central laboratory focused on compliance and quality assurance. If you are interested in this role, reach out directly to apply TODAY to Grace Williams at grawilliams@actalentservices.com.
Job Overview 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 will research regulations, 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.
Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness.
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.
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.
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.
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
Regulatory Compliance
GXP
GMP Manufacturing
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
Pay & Benefits
Pay range: $40.86 - $41.10/hr
Benefits may include Medical, Dental & Vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth; Life Insurance; Short and Long-Term Disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; PTO, Vacation, or Sick Leave.
Workplace Type This is a fully onsite position in Indianapolis, IN.
Application Deadline This position is anticipated to close on Nov 10, 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.
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Location Indianapolis, IN
Immediate Hiring Join a leading central laboratory focused on compliance and quality assurance. If you are interested in this role, reach out directly to apply TODAY to Grace Williams at grawilliams@actalentservices.com.
Job Overview 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 will research regulations, 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.
Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness.
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.
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.
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.
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
Regulatory Compliance
GXP
GMP Manufacturing
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
Pay & Benefits
Pay range: $40.86 - $41.10/hr
Benefits may include Medical, Dental & Vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth; Life Insurance; Short and Long-Term Disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; PTO, Vacation, or Sick Leave.
Workplace Type This is a fully onsite position in Indianapolis, IN.
Application Deadline This position is anticipated to close on Nov 10, 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.
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