Quality Assurance Specialist

Job Summary

The Quality Assurance (QA) Specialist is responsible for supporting the Quality Assurance program to ensure compliance with Good Laboratory Practice (GLP) regulations, Standard Operating Procedures (SOPs), study protocols, and applicable regulatory requirements (e.g., EPA, FDA, OECD).

Key Responsibilities

• Conduct audits and inspections of study activities, laboratory procedures, raw data, reports, and supporting documentation to ensure compliance with GLP regulations, SOPs, and study protocols
• Review draft and final study reports for accuracy, completeness, consistency, and traceability to raw data
• Document audit findings clearly and accurately and communicate observations to laboratory management and Study Directors
• Maintain QA records, audit schedules, inspection logs, and documentation in accordance with regulatory and record retention requirements
• Participate in facility inspections and process audits to evaluate compliance with established quality systems
• Collaborate with laboratory staff to clarify discrepancies and ensure timely resolution of quality-related issues

Qualifications

• Strong attention to detail and analytical skills
• Excellent written and verbal communication skills
• Ability to review technical and scientific documentation for accuracy and compliance
• Strong organizational and time management skills
• Ability to maintain confidentiality and objectivity in a regulated environment
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)

Pay

The hourly pay range for this role is $25.00 - 28.85 per hour.