Compliance Analyst, Quality Assurance - QA​/QC

Shift Timing: 1st Shift | 8:00 AM to 5:00 PM Mon-Fri

• 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.

• 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.

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

• 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.

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

• 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.

• 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, Track Wise) is a plus.

• ASQ Certified Quality Auditor (CQA)
• ASQ Certified Quality Manager or Quality Engineer (CQM/CQE)
• SQA Registered Quality Assurance Professional (RQAP)

• Travel:
  Occasional regional travel (5%) may be required.