GxP QC Data Reviewer: Bioanalytical Data Integrity

BioAgilytix; Durham (NC); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k with Employer Match

Paid Time Off

Parental Leave

Job summary

BioAgilytix is seeking a detail-oriented QC data reviewer to ensure the highest standards of data quality within a GxP environment. This role focuses on technical reviews of raw and processed data and requires collaboration with the QA team to maintain regulatory compliance across various assays.

Ideal candidates bring lab familiarity, self-motivation, and the ability to work independently in a deadline-driven setting.

Qualifications

• Bachelor's degree in biological science or related field with 2–10 years’ experience in biotech/pharma/CRO/CMO
• Knowledge and/or extensive knowledge of GxP regulations
• 2–4 years' experience performing data review in a GxP environment
• Experience with bioanalytical methods such as immunoassays, cell-based assays, or qPCR

Responsibilities

• Perform QC technical, scientific, and compliance review of data and documentation for regulated studies (GLP, GMP)
• Identify deviations, OOS and OOT in Bioanalytical Operations data
• Issue QC review observations and ensure data integrity
• Collect metrics data to monitor QC reviews and identify process improvements
• Educate and influence scientific staff on best practices in GxP compliance

Skills

GxP regulations

QC data review

Regulatory compliance

Data integrity

LIMS

Education

Bachelor's degree in biological science or related field

2–4 years' experience in biotech/pharma/CMO environment

Tools

Quality Management software

GxP documentation systems

Job description

BioAgilytix is seeking a detail-oriented QC data reviewer to ensure the highest standards of data quality within a GxP environment. This role focuses on technical reviews of raw and processed data and requires collaboration with the QA team to maintain regulatory compliance across various assays.

Ideal candidates bring lab familiarity, self-motivation, and the ability to work independently in a deadline-driven setting.