Quality Assurance Auditor I

Scorpion Therapeutics; Morrisville (NC); On-site; USD 65,000 - 92,000; Full time

Job summary

Scorpion Therapeutics seeks a Quality Assurance Auditor to conduct audits in GLP-regulated environments, focusing on studies, facilities, and compliance with FDA, EPA, and international GLP standards.

The role involves performing facility and process audits, reviewing documentation, preparing audit reports, supporting validation assessments, and assisting with regulatory inspections in an office or lab setting with travel for client interactions.

Qualifications

• 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: knowledge of Part 11 compliance, risk assessments, and vendor evaluations.

Responsibilities

• Conduct facility and process audits.
• Review documentation.
• Prepare audit reports.
• Support validation assessments.
• Assist with regulatory inspections.

Skills

GLP auditing

Regulatory knowledge

Documentation review

Data integrity

Education

Bachelor's degree in chemistry, life sciences, or related field

Tools

Electronic data systems

SOPs

Part 11 compliance

Job description

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

Requirements:

• 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.