On-Site QC Data Analyst: Trend & Release Insights

Regeneron Pharmaceuticals Inc.; New York (NY); On-site; USD 45,000 - 71,000; Full time

Job summary

Regeneron Pharmaceuticals Inc. is seeking an Associate QC Data Analyst to join our Quality Control team in a on-site role in New York.

You will compile, trend and report product release data, prepare Certificates and Summaries of Analysis, and support lot release and regulatory filings while collaborating with Manufacturing, QA, RA, R&D and Process Analytical Sciences. You will build tracking matrices for release and stability, maintain SOPs for data review, and ensure adherence to cGMP.

Qualifications

• BS/BA in Chemistry, Biology or related field or equivalent experience.
• Ability to comply with applicable cGMP regulations, SOPs and regulatory requirements.
• Ability to meet specified timelines in support of lot release and regulatory filings.
• Willingness to participate in required training activities.

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 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 trends.

Skills

Data analysis

cGMP compliance

Cross-functional collaboration

Education

BS/BA in Chemistry, Biology or related field

Job description

Regeneron Pharmaceuticals Inc. is seeking an Associate QC Data Analyst to join our Quality Control team in a on-site role in New York.

You will compile, trend and report product release data, prepare Certificates and Summaries of Analysis, and support lot release and regulatory filings while collaborating with Manufacturing, QA, RA, R&D and Process Analytical Sciences. You will build tracking matrices for release and stability, maintain SOPs for data review, and ensure adherence to cGMP.