QC Document Specialist (GMP) at Eurofins

Lexington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Jan, 26

Salary

34.0

Posted On

20 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Quality Assurance, GMP Principles, Regulatory Compliance, Analytical Development, Analytical Methods, Data Integrity, Technical Reports, Troubleshooting, Time Management, Multitasking, Communication Skills, Collaboration, Data Entry, Stability Studies, Certificates of Analysis

Industry

Medical and Diagnostic Laboratories

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. Join us in shaping a safer, healthier, and more sustainable world. Explore opportunities with Eurofins and be part of a global team driving scientific excellence. Apply today and make a meaningful impact! 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 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. 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. without restriction or sponsorship. Additional Information What to Expect in the Hiring Process: 10-15 Minute Phone Interview with Region Recruiter 45-60 Minute Virtual Interview with Manager and/or Group Leader 60 Minute Onsite Meeting with Team Additional Details: This is a full-time, onsite position based on a first-shift schedule (Monday through Friday, 8:00 AM to 5:00 PM), with overtime required as needed. Candidates located within a commutable distance to Lexington, MA, are strongly encouraged to apply. Occasional travel (approximately 1–2%) to the Cambridge, MA site may be required. Excellent full-time benefits include: comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Hourly rate is between $30-$34, depending on education and experience Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Responsibilities

The QC Document Specialist will collaborate with internal teams and external partners to ensure data integrity and regulatory compliance. Key tasks include reviewing analytical data, entering GMP data into validated systems, and generating Certificates of Analysis as needed.