Quality Assurance Specialist

Quality Assurance Specialist

Department

Quality Assurance

Reports To

Quality Assurance Supervisor/Manager

FLSA Status

Non-Exempt

Band

Bachelor’s degree (BA/BS) in a scientific or technical discipline preferred

Education

4

Experience

In lieu of a degree, a minimum of 4 years of related experience will be considered

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). This role performs audits, inspections, and reviews of laboratory processes, data, and reports to verify data integrity, accuracy, traceability, and compliance within a regulated laboratory environment.

The QA Specialist works closely with Study Directors, laboratory personnel, and management to identify compliance risks, communicate findings, and support corrective actions. This position requires strong attention to detail, organizational skills, and the ability to work independently while maintaining objectivity and confidentiality.

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
• Maintain confidentiality and independence in all QA activities and assessments

GLP Accountability

The Quality Assurance Specialist is accountable for supporting the organization’s GLP Quality Assurance program in accordance with FDA 21 CFR Part 58, EPA 40 CFR Parts 160, 792 and OECD Principles of Good Laboratory Practice. This includes independently monitoring study conduct, documentation, and reporting activities to verify compliance with approved protocols, SOPs, and applicable regulations.

The QA Specialist is responsible for identifying and documenting compliance concerns, supporting data integrity practices, and ensuring audit findings are appropriately communicated and tracked through resolution.

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)

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

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