QC Data Analyst

Regeneron Pharmaceuticals•Rensselaer, NY

23h•$22 - $34•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Associate QC Data Analyst to join our Quality Control team. In this role, you will compile, trend and report product release data, preparing Certificates and Summaries of Analysis and trending analyses that support lot release and regulatory filings, while collaborating with Manufacturing, QA, RA, R&D and Process Analytical Sciences. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

BS/BA in Chemistry, Biology or a related field, or an equivalent combination of education and experience
Ability to comply with applicable 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

Nice To Haves

Experience working in a cGMP pharmaceutical Quality Control laboratory

Responsibilities

Compiles internal and external data to prepare CofAs and SofAs for all lot release materials
Trends QC product release data to support lot release, regulatory filings and in-depth product reviews
Writes annual product and lot-specific release data trending reports
Partners with Manufacturing, QA, RA, R&D and Process Analytical Sciences to share status updates and trending analyses for investigations and validation studies
Builds and maintains tracking matrices and QC metrics for release and stability testing and review status
Supports the product release data trending program and improvements that streamline the review and release process
Maintains and updates SOPs for data review and reporting while ensuring cGMP compliance
Meets specified timelines and represents Quality Control in meetings with Drug Supply, External Manufacturing and QA