Quality Specialist

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.

Responsibilities for the Quality Specialist include:

·      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.

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%.

Compensation for the Quality Specialist includes:

·      Salary Range: Approximately $90,000 - $125,000+ annually *depending on experience*

·      Comprehensive Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays

This job is open for applications on 7/9/2025. Applications will be accepted at least 30 days from the posting date.

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