QC Data Reviewer - Data Integrity & Release Support

BioSpace; Town of East Greenbush (NY); On-site; USD 34,000 - 54,000; Full time

Job summary

Regeneron is seeking a Quality Control Data Reviewer to perform data review of analytical results supporting release, stability programs, and lab operations in QC. You will ensure compliance with cGMP and internal SOPs, and you will help drive timely, accurate data reporting to support product quality.

The role requires a BS/BA in Chemistry, Biology, or related field, prior cGMP-lab experience, and familiarity with electronic laboratory data systems (LIMS).

Qualifications

• Must have BS/BA in Chemistry, Biology, or related field.
• Experience in a cGMP-regulated laboratory or manufacturing environment is required.
• Familiarity with electronic laboratory data systems (e.g., LIMS) is preferred.

Responsibilities

• Execute detailed data review of analytical test results for compliance with cGMP, internal SOPs and specifications.
• Support production, stability studies, and lab operations through timely, accurate data review.
• Review release and stability data, reference standard trend charts, lab equipment calibration records, and logbooks.
• Perform detailed data review of analytical test results generated by contract testing labs to confirm correctness and accuracy.
• Maintain and update relevant SOPs for data review and reporting.
• Collaborate with Stability and other groups to support stability report writing and regulatory updates.

Skills

Attention to detail

Regulatory compliance

Data review

Education

BS/BA in Chemistry, Biology or related field

Tools

LIMS

Job description

Regeneron is seeking a Quality Control Data Reviewer to perform data review of analytical results supporting release, stability programs, and lab operations in QC. You will ensure compliance with cGMP and internal SOPs, and you will help drive timely, accurate data reporting to support product quality.

The role requires a BS/BA in Chemistry, Biology, or related field, prior cGMP-lab experience, and familiarity with electronic laboratory data systems (LIMS).