Piper Companies Health & Sciences is seeking a Quality Specialist as a direct hire to support a clinical research company in Montgomery County, MD and will include 20% travel.

QUALIFICATIONS FOR THE QUALITY SPECIALIST INCLUDE:

• Understanding of GCP and their application in clinical research to ensure ethical conduct and regulatory compliance throughout the process.
• Proven ability to support or lead preparation for audits conducted by global health authorities as well as ability to respond to findings with corrective actions.
• Familiarity with quality management systems specific to Contract Research Organization operations including documentation control, CAPA, training, and risk management processes.
• Ability to communicate clearly across all teams and with external partners both when writing and/or speaking.
• Skilled in Microsoft Office applications such as Excel, Word, PowerPoint, and Outlook.
• Must be willing to travel (domestic and international) up to 20%.

• Supporting the maintenance and upkeep of the Quality Management System to ensure it is current, compliant, and functioning effectively across all departments.
• Oversight of critical quality systems by managing training records, controlling documentation, logging and addressing customer complaints, and ensuring effective implementation and follow-up of corrective actions.
• Assists in the planning, coordination, and executing of audits to assess compliance with internal policies and regulatory standards.
• Participate in internal audits and tracks quality performance through key metrics, contributing to data- driven decisions and improvement efforts.
• Oversee periodic review and revision of controlled documents, ensuring operational practices align with documented procedures and regulatory quality standards.
• Prepares for and assists during inspections and audits conducted by regulatory agencies with all necessary documents accurate and available.