Remote GCP QA Auditor & Compliance Specialist

Piper Companies; United States; Remoto; USD 80.000 - 135.000; Tempo pieno

Vantaggi offerti da questo lavoro

Full benefits package

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GCP Audits

Clinical QA

Regulatory Compliance

GCP Regulations

MS Office

Formazione

Bachelor's degree

Descrizione del lavoro

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.