GCP Quality Assurance Specialist

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

Benefits offered by this job

PTO

Medical Insurance

Dental Insurance

401K

Job summary

Piper Companies is seeking a GCP Quality Assurance Specialist to support a leading clinical research organization. The role is remote in the U.S., with candidates located in the DMV area (MD, VA, DC) or North Carolina and periodic travel as required.

You will contribute to QMS improvements, QA training, CAPA, document control, and GCP audits across sites, vendors, and CROs. Requirements include 3–5+ years in clinical QA, strong GCP audit experience, regulatory audit support, and excellent

Qualifications

• 3–5+ years of QA experience in clinical research environments.
• 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

• 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.

Skills

Quality Assurance

GCP Audits

Regulatory Compliance

Documentation & CAPA

Training Programs

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

GCP Quality Assurance Specialist

Job Summary:

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

Responsibilities for the GCP Quality Assurance Specialist include:

• 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.

Required Qualifications for the GCP Quality Assurance Specialist include:

• 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.

Compensation for the GCP Quality Assurance Specialist includes:

• Salary Range: 80,000-120,000K annually *Based on experience*
• Full Benefits Package: PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset.

This Job opens for applications on September 22, 2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

• GCP
• Good Clinical Practice
• Quality Assurance
• QA Specialist
• GCP Auditor
• Clinical Research
• Clinical Research QA
• Internal Audits
• External Audits
• CRO
• CAPA
• Quality Management System
• QMS
• Regulatory Compliance
• FDA
• EMA
• ICH Guidelines
• Clinical Site Audits
• Vendor Audits
• Regulatory Inspections
• Document Control
• Training Program
• Bethesda
• MD
• DMV Area
• North Carolina
• Remote