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

Locations: 8211 Scicor Drive, Indianapolis, IN 46214
Anticipated Start Dates: 11/17
Expected Duration: 6 Months
Job Type: Contract with possible extension
Shift: 1st Shift, 8:00 AM to 5:00 PM Mon-Fri
Pay Rate $40.86/hr on W2.
Need: Bachelor's degree in life sciences (advanced preferred) with 6+ years in GxP/regulatory environments, expertise in quality systems, regulatory inspections, ISO 15189/13485, and risk-based auditing.
Interview Process: 1-Phone screen, 2- Virtual/Inperson with Panel


Job Description:
Department: Regulatory Compliance & Quality Assurance
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 and drug development, offering commercial diagnostic laboratory testing services within a highly regulated environment. The ideal candidate will bring deep expertise, an action-oriented mindset, and the ability to lead challenging audit activities across the global enterprise to ensure operational compliance with 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 clients 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 of 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, able to work both independently and within 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.
  
• Work Environment: Onsite role based in Indianapolis, IN.
  
• Contract Type: Contract-to-hire with potential for full-time conversion based on performance and business needs.
  

About BCforward

Founded in 1998, BCforward is a Black-owned global leader in workforce management and digital product delivery solutions, headquartered in Indianapolis, IN. With a worldwide team of over 6,000 consultants, BCforward is dedicated to empowering human potential through its core values: People-Centricity, Excellence, and Diversity.

As an industry pioneer, BCforward provides a best-in-class workplace, fostering a culture of accountability, innovation, and optimism. Committed to equal opportunity employment, the company champions diversity and inclusion, striving to create a positive impact for its clients, employees, and communities.

Interested candidates please send resume in Word format Please reference job code 246451 when responding to this ad.

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