JOB DESCRIPTION:

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.

QUALIFICATIONS FOR THE QA SPECIALIST INCLUDE:

• 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,)
• Certified Quality Auditor (CQA) preferred

• 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.