QC Data Review & Compliance Associate

This hybrid non-laboratory role supports Quality and Analytical functions with a focus on data review compliance and documentation. The QC Data Review & Compliance Associate will work closely with internal teams and external vendors to ensure data accuracy regulatory alignment and timely execution of deliverables.

Key Responsibilities

• Review and interpret analytical data; support technical reports and regulatory documentation.
• Evaluate QC testing data for small molecule and/or biologics methods from external labs.
• Enter GMP data into validated systems with precision and efficiency.
• Verify data and trending tables for inclusion in regulatory submissions.
• Build and manage stability studies within validated systems.
• Ensure GMP data aligns with specifications; generate Certificates of Analysis (COAs) as needed.
• Monitor and trend reference standards and analytical data.
• Identify and escalate technical issues or vendor concerns.
• Troubleshoot basic data-related issues using available resources.
• Collaborate with cross-functional teams under supervision.
• Travel between Lexington and Cambridge MA sites as required.

Qualifications :

• Bachelors degree in Chemistry Biology or related field.
• Minimum 2 years of relevant industry experience.
• Experience in QC QA or GMP-regulated environments required.
• Analytical Development experience preferred.
• Familiarity with biologics or small molecule analytical methods is a plus.
• Strong understanding of GMP principles and regulatory compliance.
• Effective communication and documentation skills.
• Strong time management and multitasking abilities.
• 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