About this role
Regeneron is seeking a QC Data Analyst to join our Quality Control team in Rensselaer, NY. The role focuses on compiling, trending, and reporting product release data to support lot release and regulatory filings. You will prepare Certificates and Summaries of Analysis and collaborate with Manufacturing, QA, RA, R&D, and Process Analytical Sciences to provide timely insights for investigations, validations, and reviews. This on-site position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients.
Responsibilities
- Compile internal and external data to prepare Certificates of Analysis (CoAs) and Statements of Final Analytical Results (SoFAs) for all lot release materials
- Trend QC product release data to support lot release, regulatory filings, and in-depth product reviews
- Write annual product and lot-specific release data trending reports
- Partner with Manufacturing, QA, RA, R&D, and Process Analytical Sciences to share status updates and trending analyses for investigations and validation studies
- Build and maintain tracking matrices and QC metrics for release, stability testing, and review status
- Support the product release data trending program and implement improvements to streamline the review and release process
- Maintain and update SOPs for data review and reporting while ensuring cGMP compliance
- Meet specified timelines and represent Quality Control in meetings with Drug Supply, External Manufacturing, and QA
Requirements
- BS/BA in Chemistry, Biology, or a related field, or an equivalent combination of education and experience
- Ability to comply with cGMP regulations, SOPs, and regulatory agency requirements
- Ability to meet specified timelines in support of lot release and regulatory filings
- Willingness to participate in required training activities
- Preferred: Experience working in a cGMP pharmaceutical Quality Control laboratory