Compliance Analyst III

Compliance Analyst III

BC Forward is looking for Senior QA Compliance Auditor in Indianapolis, IN 46214.


Position Title: Senior QA Compliance Auditor
Location: 8211 Scicor Drive, Indianapolis, IN 46214.
Anticipated Start Date: 01/19
Duration: 6 months
Job Type: Contract with potential for extension
Shift: Monday-Friday, 8:00 AM - 5:00 PM (EST)
Pay Rate: $40.86/hour(W2)
Need: Bachelor's degree in life sciences or a related field required (advanced degree preferred or equivalent experience considered), with a minimum of 6 years of experience in a regulatory or GxP-compliant environment, demonstrated expertise in quality systems and regulatory inspections, and strong working knowledge of ISO 15189, ISO 13485, and risk-based auditing methodologies.
Interview Process: 1-Phone Screen, 2-Virtual/ IN Person Round

Job Summary
We are seeking a highly skilled and experienced Senior QA Compliance Auditor to join our team on a contract-to-hire basis. This role supports clinical research drug development by providing commercial diagnostic laboratory testing services within a highly regulated environment.
The ideal candidate will bring deep regulatory expertise, an action-oriented mindset, and the ability to lead complex audit activities across a global enterprise. This position ensures operational compliance with GCP, GCLP, ISO 13485, ISO 15189, CAP/CLIA regulations, and applicable industry standards.

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Key Responsibilities
Audit Planning, Execution & Oversight

• Plan, schedule, and conduct audits across clinical laboratory operations and supporting 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 timely delivery for client and business stakeholders.
  

Compliance Monitoring & Issue Resolution

• Evaluate adherence to SOPs, regulatory requirements, and industry standards.
  
• Lead audit and inspection response activities, 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 enhance compliance and operational efficiency.
  

Training & Continuous Improvement

• Develop, deliver, and participate in training related to audit practices and compliance expectations.
  
• Promote a culture of quality, accountability, and continuous improvement across teams.
  

Documentation & Reporting

• Prepare comprehensive audit reports with clear, actionable recommendations.
  
• Track and report quality metrics, identifying trends and opportunities for improvement.
  
• Maintain audit documentation and ensure ongoing inspection readiness.
  

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Qualifications
Education

• Bachelor's degree in life sciences or a related field required; advanced degree preferred.
  
• Equivalent experience may be considered in lieu of advanced education.
  

Experience

• Minimum of 6 years of experience in a regulatory or GxP-compliant environment.
  
• Demonstrated experience with quality systems and regulatory inspections.
  
• Strong working knowledge of ISO 15189, ISO 13485, and risk-based auditing methodologies.
  

Skills

• Excellent communication, organizational, negotiation, and problem-solving skills.
  
• Proven ability to influence cross-functional teams and drive compliance initiatives.
  
• Ability to work successfully both independently and in dynamic, team-oriented environments.
  
• Experience with quality management systems and 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)
  

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Additional Information

• Travel: Occasional regional travel (approximately 5%) may be required.
  
• Work Environment: Onsite role based in Indianapolis, IN.
  
• Contract Type: Contract-to-hire with the potential for full-time conversion based on performance and business needs.
  

Interested candidates please send resume in Word format Please reference job code 248526 when responding to this ad.

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