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Clinical QA Specialist

1 month ago

Silver Spring, United States Piper Companies Full time

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

15% Travel Required to Local and European Clinical Sites Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulationsReviews clinical audit reports and provides guidance to auditorsPromotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management SystemHosts client audits, conduct external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigationsReviews clinical quality management plans and provides consultative support to clinical sitesSupport regulatory inspections

Requirements for the Quality Assurance Specialist

Minimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, Master’s degree preferredSolid understanding and working knowledge of GCP (minimum 5 years)Experience working with Quality Management SystemsProficiency in MS OfficeExperience with supervising staff

Compensation for the Quality Assurance Specialist

Salary up to $90,000 based on meeting of requirementsBenefits: Health, Medical, Dental & Vision insurance