- Salary
- $80k – $135k
- Location
- remote
- Workplace
- Remote
- Department
- IT
Description
GCP Quality Assurance Specialist
Job Summary:
Piper Companies is seeking a Senior GCP Quality Assurance Specialist to support a leading clinical research organization supporting regulated clinical research programs. This position is remote, with periodic travel requirements.
Responsibilities for the Senior 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 Senior 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 Senior GCP Quality Assurance Specialist includes:
Salary Range: 80,000-135,000K annually *Based on experience*
Full Benefits Package: Provided during interview process
This Job opens for applications on November 2, 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 • Remote