Clinical QA Specialist

Job Title: QA Specialist

Job Description

We are seeking a Clinical QA Specialist to join our team, to assist in conducting both internal and external audits within GCP guidelines.

Responsibilities

• Conduct clinical site audits, both domestic and international, to verify regulatory compliance and protocol adherence.
• Verify compliance with applicable Standard Operating Procedures (SOPs) and regulations.
• Review clinical audit reports and provide guidance to auditors.
• Support the inspection readiness program.
• Serve as a subject matter expert for quality.
• Promote quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System.
• Host client audits and conduct external audits at clinical and vendor sites.
• Lead process improvement activities and CAPA investigations.
• Support regulatory authority inspections.

Essential Skills

• Solid understanding and working knowledge of GCP with a minimum of 5 years of experience, or 3+ years with strong supporting experience.
• Experience working with eQMS.
• Proficiency in MS Office.
• Experience with supervising staff.

Additional Skills & Qualifications

• Minimum of a B.S/B.A. degree.
• Certified Quality Auditor (CQA) preferred.
• Advanced degree preferred.

Work Environment

The position offers flexibility with a hybrid work environment: 2 days onsite and 3 days working from home, or fully remote. Remote candidates must reside in North Carolina, Virginia, Washington D.C., or Maryland. The role includes travel 10-20% of the time, with one domestic trip every other month.

Job Type & Location

This is a Contract to Hire position based out of Bethesda, Maryland.