Quality Assurance Specialist

Smithers•Wareham, MA

2d•$25 - $29

About The Position

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.

Requirements

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)

Nice To Haves

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

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
Support 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.
Independently monitor study conduct, documentation, and reporting activities to verify compliance with approved protocols, SOPs, and applicable regulations.
Identify and document compliance concerns, support data integrity practices, and ensure audit findings are appropriately communicated and tracked through resolution.