QC Data Integrity Specialist — Release & Stability

BioSpace; City of Rensselaer (NY); Presencial; USD 34.000 - 53.000; Jornada completa

Descripción de la vacante

Regeneron is seeking a Data Reviewer to join the Industrial Operations and Product Supply (IOPS) Quality Control Chemistry team in Rensselaer, NY. The role focuses on reviewing data and test records produced by the QC Drug Product team to support product release and stability programs, ensuring data integrity and regulatory compliance.

Location is Rensselaer, New York, with a 2nd shift (Sun-Thurs) from 12:00 PM to 8:30 PM.

Formación

• BS/BA in Chemistry, Biology or related field.
• May substitute other relevant experience in lieu of educational requirement.
• Experience with GMP practices and data integrity is preferred.

Responsabilidades

• Completing detailed data review for analytical test results generated by QC for compliance with regulatory requirements, internal procedures / work instructions, and specifications
• Documenting in real time all GMP activities performed
• Reviewing release and stability data, trend charts, electronic lab records, lab equipment calibration records, and/ or logbooks
• Participating in training activities
• Participating in inspection and audit activities
• Participating in projects, such as writing and revising procedures or assisting with data integrity assessments for analytical equipment

Conocimientos

Data review

GMP awareness

Documentation

Educación

BS/BA in Chemistry, Biology or related field

Descripción del empleo

Regeneron is seeking a Data Reviewer to join the Industrial Operations and Product Supply (IOPS) Quality Control Chemistry team in Rensselaer, NY. The role focuses on reviewing data and test records produced by the QC Drug Product team to support product release and stability programs, ensuring data integrity and regulatory compliance.

Location is Rensselaer, New York, with a 2nd shift (Sun-Thurs) from 12:00 PM to 8:30 PM.