Quality Control Data Reviewer

Regeneron Pharmaceuticals • Rensselaer, NY

1d • $25 - $39 • Onsite

About The Position

Regeneron is looking for a Quality Control Data Reviewer to perform data review to support release, stability programs, and lab operation within Quality Control. This role continuously strives to follow all pertinent regulatory agency guidelines to drive performance. We offer a collaborative, science-first culture and the chance to see your work translate directly into medicines that reach patients.

Requirements

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

Responsibilities

• Execute detailed data review of analytical test results generated by QC 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
• Identify and escalate data discrepancies or trends to the appropriate teams for timely resolution
• Participate in all required training activities

Benefits

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level