Compliance Analyst III

Compliance Analyst III

BCforward is currently seeking a highly motivated Compliance Analyst III in Indianapolis, IN 46214

Position Title: Compliance Analyst III

Location: Indianapolis, IN 46214

Anticipated Start Date: 3/09/2026

Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.

Expected Duration: 6+ Months

Job Type: [FULL TIME (>%3D40 HRS WEEKLY)/ [TEMP], [ONSITE]

Pay Range: $38/Hr - $42/Hr

Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.).

Requirements:

Job Title: Compliance Analyst III

Location: Indianapolis, IN 46214
Duration: 6+ Months

Description:

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.
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Key Responsibilities
* Audit Planning, Execution & Oversight
o Plan, schedule, and conduct audits across the clinical laboratory, and operational support functions.
o Host and support sponsor-client audits and regulatory inspections
o Perform external audits of suppliers and service providers.
o .
o Support audit response development and CAPA implementation, ensuring responsiveness and delivery requirements are met for client and business stakeholders.
* Compliance Monitoring & Issue Resolution
o Evaluate adherence to SOPs, regulatory requirements, and industry standards.
o Lead the response process for audits and inspections, including CAPA development, implementation and tracking.
o Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness.
o Support global QA policy implementation and interpretation of regulatory requirements.
o Ensure compliance with applicable regulations (GCP, ISO 15189, CAP, etc.) and internal quality standards.
o Participate in global quality initiatives to improve compliance and operational efficiency.
* Training & Continuous Improvement
o Develop, deliver and participate in training on audit practices and compliance expectations.
o Promote a culture of quality and continuous improvement across teams.
* Documentation & Reporting
o Prepare detailed audit reports with actionable recommendations.
o Track and report quality metrics, identifying trends and areas for improvement.
o Maintain audit records and ensure inspection readiness.
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Qualifications
* Education:
o Bachelors degree in life sciences or related field; advanced degree preferred.
o Equivalent experience may be considered in lieu of advanced education requirements .
* Experience:
o Minimum 6 years in a regulatory or GxP-compliant environment.
o Proven experience with quality systems and regulatory inspections.
o Strong understanding of ISO 15189, ISO 13485, and risk-based auditing methodologies.
* Skills:
o Strong communication, organizational, negotiation, and problem-solving skills.
o Ability to influence cross-functional teams and drive compliance initiatives.
o Success-oriented in working both independently and in dynamic team environments.
o Proficiency with quality management system applications and/or platforms (e.g., Veeva, TrackWise) is a plus.
* Certifications (Preferred):
o ASQ Certified Quality Auditor (CQA)
o ASQ Certified Quality Manager or Quality Engineer (CQM/CQE)
o SQA Registered Quality Assurance Professional (RQAP)

Benefits
BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

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 place to work.

BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.

Interested candidates please send resume in Word format Please reference job code 250216 when responding to this ad.

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