Piper Companies
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
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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
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