GMP Data Reviewer & Compliance Analyst

Arrowhead Pharmaceuticals, Inc.; Madison (WI); On-site; USD 70,000 - 110,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Data Reviewer to independently perform technical review of laboratory data and documentation to ensure GMP/GDP compliance and data integrity.

This role evaluates data quality, identifies discrepancies, and resolves routine to moderately complex issues. The Data Reviewer will support inspection readiness, collaborate with laboratory staff and CDMOs, maintain knowledge of lab systems, and help implement improvements to data review

Qualifications

• Bachelor’s degree in chemistry or STEM with 5+ years GMP experience, or MS with 3+ years in a cGMP lab.
• Experience with analytical data review and documentation practices.
• Working knowledge of GMP/GDP and lab systems.
• Familiarity with USP, ISO, FDA and ICH guidelines is a plus.

Responsibilities

• Perform independent technical review of internal and external laboratory data.
• Evaluate data for accuracy, completeness, and GMP/specifications compliance.
• Investigate discrepancies and document impact to ensure resolution.
• Review release, stability, method validation data, IPC data and logbooks.
• Collaborate with staff and CDMOs to resolve data quality issues.
• Support audit readiness activities and inspections.

Skills

GMP Experience

Data Review

Analytical Methods

Documentation Practices

Communication Skills

Education

Bachelor's in Chemistry or STEM

MS in STEM

Tools

LIMS

HPLC/LC-MS

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Data Reviewer to independently perform technical review of laboratory data and documentation to ensure GMP/GDP compliance and data integrity.

This role evaluates data quality, identifies discrepancies, and resolves routine to moderately complex issues. The Data Reviewer will support inspection readiness, collaborate with laboratory staff and CDMOs, maintain knowledge of lab systems, and help implement improvements to data review