QC Document Specialist (GMP)

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 :

• Bachelors 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 12%) 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.

Remote Work :

No

Employment Type :

Full-time