QC Data Reviewer: Analytical Data Integrity Expert

BioSpace; Town of East Greenbush (NY); On-site; USD 34,000 - 53,000; Full time

Job summary

Regeneron is seeking a QC Data Reviewer to support data review for release, stability programs, and lab operations within Quality Control. The role emphasizes adherence to cGMP and SOPs, with a focus on data accuracy and regulatory alignment.

The position involves collaboration with stability and other groups, ongoing training, and a Monday–Saturday (Tuesday–Saturday) schedule. A BS/BA in Chemistry, Biology, or related field is required.

Qualifications

• BS/BA in Chemistry, Biology, or related field.
• Solid understanding of data review and regulatory guidelines.
• Ability to analyze data trends and ensure accuracy.

Responsibilities

• Execute detailed data review for analytical test results for compliance with cGMP, SOPs and specifications.
• Support production, stability studies, and lab operations.
• Review release and stability data, trend charts, calibration records and logbooks.
• Review data from contract testing labs to assure correctness and accuracy.
• Maintain and update relevant SOPs for data review and reporting.
• Collaborate with Stability and other groups to support stability reporting and regulatory updates.
• Participate in all vital training activities.

Skills

Data review

Regulatory compliance

Analytical thinking

Communication

Education

BS/BA in Chemistry, Biology, or related field

Job description

Regeneron is seeking a QC Data Reviewer to support data review for release, stability programs, and lab operations within Quality Control. The role emphasizes adherence to cGMP and SOPs, with a focus on data accuracy and regulatory alignment.

The position involves collaboration with stability and other groups, ongoing training, and a Monday–Saturday (Tuesday–Saturday) schedule. A BS/BA in Chemistry, Biology, or related field is required.