Piper Companies

Compensation

Full Description

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 9/22/2025. Applications for this job will be accepted for at least 30 days from the posting date. KEYWORDS: remote clinical jobs, clinical research careers, quality assurance careers, GCP jobs DMV, clinical auditing roles, CRO job openings, clinical trial jobs, regulatory affairs jobs, clinical QA remote, international audit travel, clinical site inspection jobs, Clinical QA Auditor, GCP Compliance Specialist, Clinical Quality Specialist, Clinical Research Auditor, QA Associate – Clinical Trials, Clinical Trial Auditor, Clinical Compliance Auditor, Quality Assurance Auditor, Clinical QA Consultant, GCP QA Auditor, Clinical Quality Compliance Specialist, ICH-GCP, FDA regulations, EMA guidelines, Microsoft Office, QA metrics, audit tools, quality management software, electronic document management systems (EDMS), risk-based monitoring, eTMF, CTMS, GCP auditing, Good Clinical Practice, clinical site audits, clinical research, quality assurance, QA systems, QMS, CAPA, document control, regulatory compliance, clinical trials, CRO experience, internal audits, vendor audits, site monitoring, regulatory inspections, SOP review, clinical QA, remote QA jobs, clinical quality systems, audit planning, audit execution, audit reporting, clinical compliance, clinical site monitoring, clinical operations, clinical quality management, clinical documentation, clinical audit support, clinical trial compliance, clinical site evaluation