Quality Control Data Reviewer - Onsite cGMP Lab

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 52,000 - 81,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension/retirement

401(k) company match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. (USA) is seeking a Quality Control Data Reviewer to perform detailed data review of analytical results to support release, stability programs, and lab operations in a cGMP environment.

The role is on-site in Rensselaer, NY, with a Monday–Friday schedule, 8:00am–4:30pm. A BS/BA in Chemistry or Biology and experience in regulated labs are required; familiarity with LIMS is preferred.

Qualifications

• BS/BA in Chemistry, Biology, or related field.
• Level will be determined by demonstrated experience.
• Prior experience in a cGMP-regulated laboratory or manufacturing environment.
• Familiarity with electronic laboratory data systems (e.g., LIMS).

Responsibilities

• Execute detailed data review of QC analytical results for cGMP compliance.
• Support production, stability studies, and lab operations via timely data review.
• Review release/stability data, reference trends, calibration records, and logbooks.
• Review data from contract labs to confirm correctness.
• Maintain and update SOPs for data review and reporting.
• Collaborate with Stability and other groups on stability reports.
• Identify data discrepancies and escalate to teams for resolution.
• Participate in required training.

Skills

Data review

cGMP

LIMS

SOPs

QA collaboration

Education

BS/BA in Chemistry, Biology, or related field

Tools

LIMS

Job description

Regeneron Pharmaceuticals, Inc. (USA) is seeking a Quality Control Data Reviewer to perform detailed data review of analytical results to support release, stability programs, and lab operations in a cGMP environment.

The role is on-site in Rensselaer, NY, with a Monday–Friday schedule, 8:00am–4:30pm. A BS/BA in Chemistry or Biology and experience in regulated labs are required; familiarity with LIMS is preferred.