Stability Data Specialist - GMP/Regulatory (Hybrid)

Eurofins; Lexington (MA); Hybrid; 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

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.