Clinical Research QA Specialist

ZP Group•Bethesda, MD

69d•$90,000 - $120,000•Hybrid

About The Position

Piper Companies is seeking a QA Specialist that's well-versed in Infor to join a rapidly growing organization based in a hybrid capacity in Bethesda, MD.

Requirements

Bachelors degree and minimum five years' of GCP auditing experience.
Demonstrated eQMS and MS Office experience
Travel: 20% Local, Domestic, and International (NIH, Mid-west, California, Amsterdam,)

Nice To Haves

Certified Quality Auditor (CQA) preferred

Responsibilities

Acts as a Subject Matter Expert (SME) for quality.
Enhances quality by reviewing work instructions, training staff, and supporting the Quality Management System.
Facilitates client audits, conducts external audits at clinical and vendor sites, and leads process improvement activities and CAPA investigations.
Performs clinical site audits (both domestic and international) to ensure regulatory and protocol compliance.
Ensures clinical compliance with applicable Standard Operating Procedures (SOPs) and regulations.
Reviews clinical audit reports and provides guidance to auditors.
Supports the inspection readiness program.