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Senior QA Compliance Auditor (Indianapolis)
Senior QA Compliance Auditor (Indianapolis)SPECTRAFORCE • Indianapolis, IN, United States
Senior QA Compliance Auditor (Indianapolis)

Senior QA Compliance Auditor (Indianapolis)

SPECTRAFORCE • Indianapolis, IN, United States
1 day ago
Job type
  • Full-time
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 :

  • Bachelors 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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    Compliance Auditor • Indianapolis, IN, United States