QC Data Analyst: Trend & Release Insights (On-Site)

Regulatory Jobs; City of Rensselaer (NY); Presencial; USD 30.000 - 47.000; Jornada completa

Descripción de la vacante

Regeneron in Rensselaer, NY, is seeking an Associate QC Data Analyst to join the Quality Control team. You will compile, trend and report product release data, prepare CofAs and SofAs, and support lot release and regulatory filings while collaborating with Manufacturing, QA, RA, R&D and Process Analytical Sciences.

You will build tracking matrices and QC metrics, maintain SOPs and ensure cGMP compliance, meeting deadlines and contributing to investigations and validation studies.

Formación

• BS/BA in Chemistry, Biology or related field.
• Ability to comply with cGMP regulations and SOPs.
• Ability to meet timelines for lot release and regulatory filings.
• Willingness to participate in required training activities.
• Experience in a cGMP pharmaceutical QC laboratory is preferred.

Responsabilidades

• 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

Conocimientos

Data analysis

Trend analysis

Data reporting

Educación

BS/BA in Chemistry or Biology

Descripción del empleo

Regeneron in Rensselaer, NY, is seeking an Associate QC Data Analyst to join the Quality Control team. You will compile, trend and report product release data, prepare CofAs and SofAs, and support lot release and regulatory filings while collaborating with Manufacturing, QA, RA, R&D and Process Analytical Sciences.

You will build tracking matrices and QC metrics, maintain SOPs and ensure cGMP compliance, meeting deadlines and contributing to investigations and validation studies.