Piper Companies (Health & Sciences) is currently seeking motivated candidates for a Quality Assurance Specialist (GCP) - Fully Remote opportunity in Montgomery County, MD to assist an established clinical research and pharmaceutical support company with ongoing clinical trial audits and quality assurance activities.
Responsibilities for the Quality Assurance Specialist
Travel Required to Local and European Clinical Sites
- Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations
- Reviews clinical audit reports and provides guidance to auditors
- Promotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System
- Hosts client audits, conduct external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations
- Reviews clinical quality management plans and provides consultative support to clinical sites
- Support regulatory inspections
Requirements for the Quality Assurance Specialist
- Minimum a B.S / B.A., Certified Quality Auditor (CQA) preferred, Master’s degree preferred
- Solid understanding and working knowledge of GCP (minimum 5 years)
- Experience working with Quality Management Systems
- Proficiency in MS Office
- Experience with supervising staff
Compensation for the Quality Assurance Specialist
- Salary up to $, based on meeting of requirements
- Benefits : Health, Medical, Dental & Vision insurance
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