QC Data Reviewer - LNP and Lipids

Eurofins Professional Scientific Services provides analytical testing services to ensure product safety, authenticity, and regulatory compliance across industries like food, environmental, pharmaceutical, and cosmetics. We support professional growth and work-life balance while contributing to a safer, healthier, and more sustainable world.

About the role

This non-laboratory position involves reviewing and evaluating analytical quality data for LNP formulations and lipid materials across stability studies, method development, and investigations. The role requires attention to detail, familiarity with GMP practices, and a commitment to data integrity and regulatory compliance.

Responsibilities

• Review analytical data packages from stability studies, method development, and investigations for LNP and lipid-based products.
• Evaluate OOS/OOT investigation reports for completeness, scientific soundness, and appropriate corrective actions.
• Verify calculations, data transcriptions, and chromatographic data for accuracy and compliance.
• Ensure documentation adheres to GMP and applicable regulatory guidelines.
• Maintain review timelines and tracking logs to support release and regulatory submission deadlines.
• Partner with analytical and quality teams to resolve data discrepancies and review findings.

Requirements

• B.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• 3-4 years of analytical laboratory experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Proficiency in GMP regulations and Good Documentation Practices.
• Understanding of chromatography operation and data interpretation.
• Strong organizational skills, attention to detail, and accuracy in documenting results.
• Strong time management and multitasking abilities.
• Ability to work independently and collaborate in a cross-functional environment.
• Effective communication and documentation skills.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Preferred Qualifications

• Experience interpreting chromatographic data such as HPLC, UPLC, and LC-MS (chromatography data review experience is a plus).
• Familiarity with LNP and lipid technologies and investigations.
• Experience with method development.
• Experience with software systems such as SLIM, Veeva, JMP, and LIMS.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.

Pay

Hourly rate between $36.00 and $40.00, depending on education and experience.

Schedule

Full-time, Monday through Friday, 8:00 AM to 5:00 PM.

Candidates currently living within a commutable distance of Boston, MA are encouraged to apply.