QC Data Reviewer - LNP and Lipids
$74,880–$83,200 year
On-siteBoston, Massachusetts, United States
Job Summary
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. This non-laboratory role requires a B.S. in Chemistry or related field with 3-4 years of GMP experience and proficiency in GMP regulations. Full-time position Monday-Friday, 8am-5pm, located for candidates within commutable distance of Boston, MA, with an annual rate between $36.00-$40.00.
Required Qualifications
- 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 how chromatography is operated and how to interpret the data
- 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
Desired Qualifications
- Experience with chromatograms and the ability to interpret chromatographic data such as HPLC, UPLC, and LC-MS
- 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
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