Quality Assurance Associate (Remote)

Quality Assurance Associate - Full-time - 100% Remote

Our Pharmaceutical Client is looking for an experienced Quality professional to join their growing team!

The Quality Assurance Associate (QAA) conducts audits and performs compliance-related services based on experience and a comprehensive understanding of regulatory requirements and ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP).

Responsibilities include but are not limited to:

• Provide recommendations for audit observations.
• Assist with external and site audits as requested.
• Conduct internal process and system quality audits.
• Serve as QA review for contractor qualification assessment.
• Conduct internal project audits as assigned.
• Conduct supplier qualification assessments.

Minimum Requirements:

• Fully and consistently able to demonstrate tact, diplomacy, discretion, and good judgment.
• Minimum of 5 years’ experience in clinical research.
• Experience as a QA Associate/Clinical Quality Auditor or in compliance/utilization review preferred.
• Strong working knowledge of FDA-regulated research, ICH Guidelines and GCP.
• Open to new challenges, reliable, flexible, and able to work independently.
• Certification in clinical research or regulatory affairs preferred.
• Bachelor’s degree preferred (or equivalent knowledge/experience)
• Strong, professional interpersonal skills including ability to communicate effectively with people individually and in groups.

Interested in learning more? Reach out directly: [email protected] or (646) 822-3491