GCP Quality Assurance Specialist

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

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.

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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