GMP Quality Data Reviewer (Analytical Testing)

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health and wellness programs

Stock for employees

Fitness centers

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC Specialist for the 1st shift (Mon-Fri, 8:00am–4:30pm) to support QC External Testing with data review of analytical results from Advanced Therapies.

You will review Release, In-Process, and Stability data, verify documentation for method qualification, transfer and validation, and ensure compliance with cGMP, GDP, FDA/EMA/ICH guidelines and ALCOA+ principles. Strong attention to detail and teamwork are essential.

Qualifications

• Bachelor's degree in a scientific field or equivalent experience.
• 2 years of related experience in a GMP/GxP environment preferred.
• Experience performing data review of analytical results and documentation.

Responsibilities

• Review Release, In-Process, and Stability data in Advanced Therapies.
• Evaluate analytical method qualification, verification, transfer, and validation docs.
• Ensure data compliance with cGMP, GDP, FDA/EMA/ICH guidelines.
• Verify data per ALCOA+ principles.
• Monitor adherence to laboratory procedures and approved protocols.
• Collaborate with lab personnel to address documentation errors.
• Provide guidance to QC analysts on Good Documentation Practices.

Skills

Data review

cGMP compliance

ALCOA+

Analytical methods

Communication

Attention to detail

GMP experience

Education

BS/BA in a scientific field

Job description

Regeneron Pharmaceuticals, Inc. is seeking a QC Specialist for the 1st shift (Mon-Fri, 8:00am–4:30pm) to support QC External Testing with data review of analytical results from Advanced Therapies.

You will review Release, In-Process, and Stability data, verify documentation for method qualification, transfer and validation, and ensure compliance with cGMP, GDP, FDA/EMA/ICH guidelines and ALCOA+ principles. Strong attention to detail and teamwork are essential.