Data Reviewer, Analytical Development

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

Position

The Data Reviewer independently performs technical review of laboratory data and documentation to ensure compliance with analytical methods, specifications, GMP/GDP requirements, and data integrity standards. This role exercises independent judgment in evaluating data quality, identifying discrepancies, and resolving routine to moderately complex compliance issues. The Data Reviewer supports inspection readiness activities, contributes to continuous improvement initiatives, and serves as a technical resource to junior team members.

Responsibilities

• Perform independent technical review of internal and external laboratory data
• Evaluate data for accuracy, completeness, and compliance with GMP and specifications
• Investigate and document discrepancies, atypical results, and documentation inconsistencies to determine impact and ensure appropriate resolution
• Review routine release and stability data, method validation reports, IPC data, cleaning samples, and logbooks for traceability and compliance
• 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 effective review
• Recommend and support implementation of improvements to data review processes, documentation practices, and workflow efficiency
• Provide guidance and onboarding support to junior reviewers on review practices, documentation standards, and GMP expectations
• Embrace digital tools and opportunities for trend analysis, system suitability trending
• Perform additional duties as assigned in support of operations

Requirements

• Bachelor’s degree in chemistry or any STEM degree and 5+ years GMP experience, or a Master of Science (STEM) with minimum 3 years of experience in a cGMP laboratory (pharmaceutical CMO/CRO)
• Experience with analytical data review and documentation practices
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, LC‑MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry and microbiology testing
• Working knowledge of GMP/GDP and laboratory systems

Preferred

• Working knowledge of USP, ISO, FDA and ICH guidelines
• Familiarity with laboratory information systems, LIMS
• Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment
• Solid organizational skills with ability to adapt to changing priorities and deadlines

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.