Stability Data Specialist

Eurofins; Lexington (MA); On-site; USD 43,000 - 48,000; Full time

Benefits offered by this job

Comprehensive medical coverage, dental

Vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Yearly bonus & merit-based increases

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a Quality/Analytical professional for a hybrid, non-laboratory role based in Lexington, MA. You will collaborate with internal and external partners to ensure data integrity and regulatory compliance, with responsibilities spanning data review, regulatory documentation, and COA generation.

The ideal candidate has a Bachelor's in Chemistry or Biology, at least 2 years in GMP/QC/QA, strong communication, and the ability to work cross-functionally.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related field.
• Minimum of 2 years of relevant industry experience.
• Experience in Quality Control, Quality Assurance, or GMP environment.
• GMP knowledge and regulatory compliance.
• Authorized to work in the U.S. without sponsorship.

Responsibilities

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

Skills

Communication skills

Time management

Multitasking

Documentation

Education

Bachelor's degree in Chemistry, Biology, or related field

Job description

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.

Key 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 escalation routine technical issues or vendor-related concerns.
• Troubleshoot basic issues using available resources and guidance.
• Travel between Lexington and Cambridge client sites as needed.

Qualifications

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

Position is Full Time, Monday-Friday, 8am-5pm.

Candidates currently living within a commutable distance of Lexington, MA are encouraged to apply. Occasional travel (approximately 1-2%) to the Cambridge, MA site may be required.

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for yearly goal-based bonus & merit-based increases

Compensation: $31.00-$35.00 per hour based on education and related experience

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.