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 % 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 %.
Compensation for the Quality Specialist includes:
·Salary Range: Approximately $, - $,+ annually *depending on experience*
·Comprehensive Benefits: Medical, Dental, Vision, k, PTO, Paid Holidays
This job is open for applications on 7/9/5. Applications will be accepted at least days from the posting date.
Quality Specialist, GCP, Inspection Readiness, CAPA, Internal audits, QMS, ICH guidelines, Regulatory Agency Audits, FDA, EMA, Compliance Monitoring, Audit Support, Audit trail documentation, SOP Adherence, Document Control System, Quality Risk Assessment, DCS Administration, Learning management System, LMS, CRO, Contract Research Organization
Quality Specialist • Bethesda, MD
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