The Quality Assurance Specialist at ProTrials Research, Inc. ensures corporate operations align with FDA, ICH, and GCP regulations by conducting audits, monitoring quality systems, and proactively identifying and resolving compliance issues. This role plays a key part in maintaining controlled documents, training systems, and organizational readiness for inspections while supporting continuous improvement and operational excellence.
What You'll Do
- Ensure corporate operations align with FDA, ICH, and GCP regulations
- Conduct audits
- Monitor quality systems
- Proactively identify and resolve compliance issues
- Oversee controlled documents
- Oversee training systems
- Support inspection readiness
- Partner cross-functionally to drive CAPA activities
- Drive continuous improvement
- Provide quality oversight
- Perform metrics analysis
- Provide ongoing support to strengthen compliance and operational excellence across the organization
What We're Looking For
- Strong knowledge of regulated clinical research environments
Benefits & Compensation
- Join a collaborative community helping to build a healthier world
- Balance a meaningful workload with life’s every-day moments
- Happier, healthier, and more successful employees due to work-life balance support
Culture & Environment
- Committed to do work that matters
- Helping patients, caregivers, and loved ones
- Collaborative community
- Building a healthier world
- Supports work-life balance
