Remote GCP QA Specialist | Audits, CAPA & QMS

ZP Group; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

Piper Companies seeks a GCP Quality Assurance Specialist to support a leading clinical research organization. This remote role requires candidates located in the DMV area (MD, VA, DC) or North Carolina, with periodic travel.

You will maintain the Quality Management System, administer QA training, conduct GCP audits, and drive continual quality improvements in collaboration with clinical research stakeholders. A Bachelor’s degree and 3–5+ years QA experience are required.

Qualifications

• 3–5+ years of QA experience in clinical research environments.
• Hands-on GCP site audits (internal and external).
• Experience supporting regulatory agency audits and CRO QA systems.
• Knowledge of current Good Clinical Practice (GCP) regulations and compliance.
• Excellent written and verbal communication with proficiency in Office tools.

Responsibilities

• Maintain and improve 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.

Skills

GCP regulations knowledge

Audits

Quality Assurance

Communication skills

Microsoft Office

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Piper Companies seeks a GCP Quality Assurance Specialist to support a leading clinical research organization. This remote role requires candidates located in the DMV area (MD, VA, DC) or North Carolina, with periodic travel.

You will maintain the Quality Management System, administer QA training, conduct GCP audits, and drive continual quality improvements in collaboration with clinical research stakeholders. A Bachelor’s degree and 3–5+ years QA experience are required.