GMP Data Reviewer – Analytical Lab Compliance

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Arrowhead Pharmaceuticals in Wisconsin is seeking a Data Reviewer to independently perform technical review of laboratory data, ensuring GMP/GDP compliance and data integrity.

The role involves evaluating data quality, investigating discrepancies, supporting audits, and guiding junior reviewers while contributing to continuous improvement in review processes and documentation standards.

Qualifications

• Bachelor’s degree in chemistry or any STEM field with 5+ years GMP experience, or MSc with minimum 3 years in a cGMP laboratory
• Experience with analytical data review and documentation practices
• Working knowledge of analytical methods (HPLC, GC, LC-MS, NMR, FTIR, pH, KF, UV) and microbiology testing
• Knowledge of GMP/GDP and laboratory systems

Responsibilities

• Perform independent technical review of laboratory data
• Evaluate data for accuracy, completeness and compliance with GMP and specifications
• Investigate discrepancies and document impact to ensure resolution
• Review release and stability data, method validation reports, IPC data, logs for traceability
• Communicate and collaborate with laboratory staff and CDMOs to resolve data quality issues
• Support audit readiness activities and participate in inspections
• Maintain knowledge of laboratory systems and software for review
• Recommend improvements to data review processes and documentation practices

Skills

Analytical data review

Documentation practices

Communication skills

Data integrity

Education

Bachelor’s degree in Chemistry or STEM

Master of Science (STEM)

Tools

LIMS

Job description

Arrowhead Pharmaceuticals in Wisconsin is seeking a Data Reviewer to independently perform technical review of laboratory data, ensuring GMP/GDP compliance and data integrity.

The role involves evaluating data quality, investigating discrepancies, supporting audits, and guiding junior reviewers while contributing to continuous improvement in review processes and documentation standards.