Quality Assurance Auditor
Job in
Morrisville, Wake County, North Carolina, 27560, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Role:
Quality Assurance Auditor within GLP-regulated environments, focusing on audits of studies, facilities, and compliance with FDA, EPA, and international GLP standards.
Responsibilities:- conduct facility and process audits
- review documentation
- prepare audit reports
- support validation assessments
- assist with regulatory inspections
- Bachelor’s degree in chemistry, life sciences, or related field
- 2-4 years of experience in GLP or similar regulated settings, preferably with auditing expertise
- strong understanding of regulatory requirements, data integrity, and quality systems
- proficiency with electronic data systems and SOPs
- preferred qualifications include knowledge of Part 11 compliance, risk assessments, and vendor evaluations
High-Value: GLP compliance, audit execution, FDA/EPA standards, validation oversight, electronic data systems, and regulatory inspection support.
Work setup:
Office or laboratory environment; travel is expected for inspections and client interactions; physical activity includes moderate movement and laboratory safety protocols.
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