Stability Data Specialist

Eurofins USA PSS Insourcing Solutions

Lexington (MA)

Hybrid

USD 43,000 - 48,000

Full time

8 days ago

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Benefits offered by this job

Medical, dental, vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Bonus potential

Job summary

Eurofins USA PSS Insourcing Solutions in Lexington, MA is hiring for a hybrid, non-laboratory role supporting Quality and Analytical functions. You will collaborate with internal teams and external partners to ensure data integrity, regulatory compliance, and timely deliverables.

The role requires a Bachelor's in Chemistry or related field, 2+ years in GMP environments, and strong documentation skills. Occasional travel to Cambridge is expected.

Qualifications

Bachelor's degree in Chemistry, Biology, or a related field.
2+ years of relevant industry experience.
Experience in Quality Control, Quality Assurance, or GMP-regulated environment.
Experience in Analytical Development preferred.
Familiarity with analytical methods for biologics or small molecule products is a plus.
Strong GMP principles and regulatory compliance.
Strong communication and documentation skills.
Authorized to work in the U.S. permanently without sponsorship.

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.

Skills

Quality Control

Regulatory compliance

Communication

Time management

Team collaboration

Education

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

Tools

Validated database systems

COA generation workflow software

Job description

Company Description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

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

Additional Information

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.

Excellent full-time benefits include: