GCP Quality Assurance Specialist

About the role

Piper Companies is seeking a GCP Quality Assurance Specialist to support a leading clinical research organization in regulated clinical research programs. This position is remote, with candidates required to be located in the DMV area (Maryland, Virginia, Washington, D.C.) or North Carolina. Periodic travel is required.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS).
• Administer QA training, document control, CAPA, and customer complaint programs.
• Conduct and support GCP audits of clinical sites, vendors, and suppliers.
• Perform internal audits and track quality metrics for continual improvement initiatives.
• Manage QA-controlled document review cycles to ensure procedural compliance.
• Collaborate with clinical research stakeholders to maintain GCP compliance.
• Support regulatory authority inspections and audit readiness activities.

Requirements

• 3–5+ years of Quality Assurance experience within clinical research environments.
• Strong hands-on experience conducting GCP clinical site audits (internal and external).
• Experience supporting regulatory agency audits and CRO quality systems.
• Knowledge of current Good Clinical Practice (GCP) regulations and compliance requirements.
• Excellent written and verbal communication skills with proficiency in Microsoft Office.
• Bachelor’s degree required.

Pay

Salary Range: $80,000–$120,000 annually (based on experience).

Benefits

• Paid Time Off (PTO)
• Paid Holidays
• Medical, Dental, and Vision insurance
• 401K retirement plan
• Tuition Reimbursement
• Paid Maternity Leave
• Military Reserve Pay Offset