QC Data Reviewer - LNP and Lipids

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 non-laboratory role is responsible for 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 the ability to ensure data integrity and regulatory compliance.

• 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.

Qualifications

Minimum Required Qualifications:

• B.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3-4 years of analytical laboratory experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Experience with chromatograms and the ability to interpret chromatographic data such as HPLC, UPLC, and LC-MS (experience with chromatography data review is a plus).
• Proficiency in GMP regulations and Good Documentation Practices.
• 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.

Preferred Qualifications:

• Familiarity with LNP and lipid technologies and investigations.
• Experience with method development.
• Experience with software systems such as SLIM, Veeva, JMP, and LIMS.
• Authorization to work in the United States indefinitely 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
• 30 Minute In-Person Onsite Meeting with the Team

_**Additional Details:**_

The position is Full Time, Monday-Friday, 8am-5pm. Candidates currently living within a commutable distance of Boston, MA are encouraged to apply.

_**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
• Annual rate is between $36.00-$40.00, depending on education and experience

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply