Clinical Research QA Specialist

ZP GroupBethesda, MD
69d$90,000 - $120,000Hybrid

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.

Benefits

  • Healthcare
  • Dental
  • Vision
  • 401k
  • Paid Time Off
  • Sick Leave (if required by law)

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Professional, Scientific, and Technical Services

Number of Employees

251-500 employees

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