GCP Quality Assurance Specialist

Piper Companies; United States; Remote; USD 80,000 - 135,000; Full time

Benefits offered by this job

Full benefits package

Job summary

Piper Companies is seeking a Senior GCP Quality Assurance Specialist to support regulated clinical research programs. This remote role includes periodic travel and offers a full benefits package.

You will maintain the Quality Management System, conduct GCP audits, manage document control, CAPA, and drive continual improvement while ensuring compliance with FDA/EMA and ICH guidelines. Collaboration with stakeholders is essential to success.

Qualifications

• 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.

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

GCP Audits

Clinical QA

Regulatory Compliance

GCP Regulations

MS Office

Education

Bachelor's degree

Job description

GCP Quality Assurance Specialist

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

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