GCP Auditor/Quality Specialist

Piper Companies is hiring a GCP Auditor/Compliance Specialist to support quality assurance within a clinical research team based in the Montgomery County area. This full-time hybrid role requires two (2) onsite days per week and involves occasional domestic and international travel for site audits. The ideal candidate thrives in a fast-paced, collaborative environment and is dedicated to maintaining compliance with Good Clinical Practice (GCP) guidelines and regulatory standards throughout clinical trial operations.

Responsibilities of the GCP Auditor/Compliance Specialist Include:

• Perform audits of clinical trial sites to ensure adherence to Good Clinical Practice (GCP) guidelines.
• Contribute to the development and maintenance of the Quality Management System (QMS).
• Oversee QA functions including training programs, document control, customer complaint handling, and CAPA processes.
• Participate in internal audits and help drive continuous improvement through performance metrics.
• Review and update QA-controlled documentation to ensure alignment with current procedures.
• Assist in audits of vendors and suppliers and provide support during regulatory inspections.

Qualifications of the GCP Auditor/Compliance Specialist Include:

• Bachelor’s degree required.
• Demonstrated experience in clinical site GCP auditing is essential (candidates must have GCP experience; GMP/GLP-only backgrounds are not sufficient).
• Understanding of regulatory audit processes and quality systems within Contract Research Organizations (CROs).
• Solid grasp of current GCP regulations.
• Strong communication skills, both written and verbal.
• Proficiency in Microsoft Office applications.

Compensation of the GCP Auditor/Compliance Specialist Includes:

• Salary Range: $55,000.00 - $110,000.00 per year, based on experience and certifications (accepting both associate and specialists level applicants)
• Comprehensive Benefits: CIGNA Medical, Dental, Vision; 401k through ADP

This job opens for applications on 10/30/2025. Applications for this job will be accepted for at least 30 days from the posting date.

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