Work Location: Middlesex County, Massachusetts

Summary:

Seeking a detail-oriented and motivated professional to support quality assurance and facility compliance programs in a non-GLP, research-focused environment. This role collaborates with quality and scientific teams to ensure scientific rigor, data integrity, and high-quality deliverables.

Responsibilities:

• Administer document control systems, including formatting, routing, and version management of policies and SOPs.
• Manage both physical and digital archives, ensuring secure storage, accurate indexing, and controlled retrieval of data and study files.
• Log, track, and follow up on deviations, CAPAs, and change controls to ensure timely documentation and resolution.
• Compile and report basic quality metrics to assist management in trend analysis and continuous improvement.
• Support audit readiness by preparing documentation, ensuring facility compliance, and participating in internal and external audits.
• Maintain approved vendor lists, track vendor qualification statuses, and assist with quality agreement renewals.
• Track laboratory equipment calibration schedules and maintain training matrices to ensure compliance with SOPs.
• Monitor sample management processes and support environmental health and safety walk-throughs to maintain a safe laboratory environment.

Qualifications:

• Bachelor’s or Master’s degree in Biology, Bioengineering, Life Sciences, or a related field.
• 0-2 years of experience in a laboratory, quality, or clinical setting; industry internships or academic lab management experience are highly welcomed.
• Basic understanding of quality systems (deviations, CAPAs, audits); familiarity with GxP concepts is a plus.
• High digital literacy and proficiency in Microsoft Office Suite, with the ability to quickly learn new electronic tracking and document control systems.
• Self-starter with a results-oriented approach, able to work independently, prioritize tasks, and deliver high-quality work with minimal supervision.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional scientific teams.

Published Category: Quality & Validation