QC Data Reviewer — cGMP Compliance & Analysis

BioSpace; Town of East Greenbush (NY); On-site; USD 67,000 - 110,000; Full time

Benefits offered by this job

Health and wellness programs

Fitness centers

Stock for employees

Job summary

Regeneron is seeking a QC Specialist on 1st shift (Mon-Fri, 8:00am–4:30pm) to perform data review of analytical test results in support of QC External Testing operations, including Release, In-Process, and Stability testing in Advanced Therapies. The role requires a BS/BA in a scientific field, 2 years of related experience, and strong attention to detail.

You will ensure data comply with cGMP, GDP, FDA, EMA, and ICH guidelines, uphold ALCOA+ data integrity, and work with LC, pH, iCIEF, ELISA,

Qualifications

• BS/BA in a scientific field required.
• 2 years of related experience.
• Experience in a GMP setting.
• Strong attention to detail and accuracy.
• Ability to review Release, In-Process, and Stability data.
• Knowledge of ALCOA+ data integrity.

Responsibilities

• Perform data review for Release, In-Process, and Stability testing in Advanced Therapies.
• Evaluate analytical method Qualification, Verification, Transfer, and Validation documentation.
• Ensure data complies with cGMP, GDP, FDA, EMA, and ICH guidelines via reviews.
• Verify data meets ALCOA+ principles and integrity.
• Monitor compliance with laboratory procedures and approved protocols.
• Collaborate with lab personnel to address documentation issues and promote cGMP culture.
• Demonstrate attention to detail and multitasking when reviewing data.
• Provide guidance to QC analysts to improve Good Documentation Practices.
• Complete tasks within timeframes and manage open tasks and timelines.
• Support QA events, deviations, and investigations as required.

Skills

Data review

ALCOA+

cGMP knowledge

Regulatory guidelines

Analytical methods

Education

BS/BA in a scientific field

Tools

iCIEF

ELISA

LC/SEC/CE-SDS

pH measurement

Job description

Regeneron is seeking a QC Specialist on 1st shift (Mon-Fri, 8:00am–4:30pm) to perform data review of analytical test results in support of QC External Testing operations, including Release, In-Process, and Stability testing in Advanced Therapies. The role requires a BS/BA in a scientific field, 2 years of related experience, and strong attention to detail.

You will ensure data comply with cGMP, GDP, FDA, EMA, and ICH guidelines, uphold ALCOA+ data integrity, and work with LC, pH, iCIEF, ELISA,