Remote GCP QA Specialist: Clinical Compliance & Audits

Zachary Piper Solutions; United States; Remote; USD 80,000 - 120,000; Full time

Benefits offered by this job

PTO

Paid Holidays

Medical

Dental

Vision

401K

Tuition Reimbursement

Paid Maternity Leave

Military Reserve Pay Offset

Job summary

Piper Companies is seeking a GCP Quality Assurance Specialist to support regulated clinical research programs. This remote role requires residence 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 manage CAPA and document review cycles, ensuring ongoing GCP compliance. Qualifications include 3–5+ years in clinical QA, hands-on GCP site audits, regulatory audit experience, strong

Qualifications

• 3–5+ years of QA 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.

Responsibilities

• Maintain and continuously 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 Audits

QA in Clinical Research

Regulatory Compliance

MS Office

Communication

Education

Bachelor's degree

Job description

Piper Companies is seeking a GCP Quality Assurance Specialist to support regulated clinical research programs. This remote role requires residence 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 manage CAPA and document review cycles, ensuring ongoing GCP compliance. Qualifications include 3–5+ years in clinical QA, hands-on GCP site audits, regulatory audit experience, strong