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Senior QA Compliance Auditor
Senior QA Compliance AuditorBCForward • Indianapolis, IN, US
Senior QA Compliance Auditor

Senior QA Compliance Auditor

BCForward • Indianapolis, IN, US
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Job Description

Job Description

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

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.

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.

    • Company Description

    About BCforward :

    Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.

    BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.

    BCforward is an equal opportunity employer.

    Company Description

    About BCforward : \r\n\r\nFounded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.\r\n\r\nBCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.\r\n\r\nBCforward is an equal opportunity employer.

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    Compliance Auditor • Indianapolis, IN, US