Stability Data Specialist

Eurofins•Lexington, MA

12h•$31 - $35•Hybrid

About The Position

This is a hybrid, non-laboratory role supporting Quality and Analytical functions. The successful candidate will collaborate with internal teams and external partners to ensure data integrity, regulatory compliance, and timely execution of deliverables.

Requirements

Bachelor’s degree in Chemistry, Biology, or a related field.
Minimum of 2 years of relevant industry experience.
Prior experience in Quality Control, Quality Assurance, or a GMP-regulated environment is required.
Solid understanding of GMP principles and regulatory compliance.
Strong communication skills; able to document and report issues clearly and promptly.
Effective time management and multitasking abilities in a cross-functional team setting.
Must be authorized to work in the U.S. permanently without restriction or sponsorship

Nice To Haves

Experience in Analytical Development is preferred.
Familiarity with analytical methods for biologics or small molecule products is a plus.

Responsibilities

Collaborate with departmental colleagues to complete assignments under supervision.
Review and interpret analytical data with client support; contribute to technical reports and regulatory documentation.
Evaluate QC testing data for small molecule and/or biologics methods from external vendor laboratories.
Enter GMP data into validated database systems accurately and efficiently.
Verify data and trending tables for inclusion in regulatory submissions.
Build and manage stability studies within validated systems, as applicable.
Ensure GMP data aligns with current specifications; generate Certificates of Analysis (COAs) when required.
Monitor and trend reference standards and analytical data.
Identify and escalate routine technical issues or vendor-related concerns.
Troubleshoot basic issues using available resources and guidance.
Travel between Lexington and Cambridge client sites as needed.