Data Reviewer, Quality Control

Scorpion Therapeutics; Madison (WI); On-site; USD 95,000 - 125,000; Full time

Job summary

Scorpion Therapeutics in Madison, WI, is seeking a detail-oriented Data Reviewer to perform independent technical reviews of laboratory data, ensuring accuracy, completeness, and GMP alignment. The role involves collaboration with staff and CDMOs, trend analysis, and supporting inspections.

A strong background in analytical chemistry and documentation is essential. The ideal candidate holds a chemistry or STEM degree with 5+ years GMP experience, or an MS in STEM with 3+ years in a cGMP lab.

Qualifications

• Bachelor’s degree in chemistry (or any STEM degree) and 5+ years GMP experience, or Master of Science (STEM) with 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, Appearance, pH, KF, UV spectrometry) and microbiology testing.
• Working knowledge of GMP/GDP and laboratory systems.
• Candidates must have current, valid authorization to work in the country where this role is located.

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 data and report, IPC data, cleaning samples, and logbooks for traceability and compliance.
• Communicate/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 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 for trend analysis and system suitability trending.
• Perform additional duties as assigned.

Education

Bachelor’s degree in chemistry (or any STEM degree)

Master of Science (STEM)

Tools

LIMS

Analytical instruments (HPLC, GC, LC-MS, NMR, FTIR, UV, pH, KF)

Job description

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 data and report, IPC data, cleaning samples, and logbooks for traceability and compliance
• Communicate/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 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 for trend analysis and system suitability trending
• Perform additional duties as assigned

Requirements:

• Bachelor’s degree in chemistry (or any STEM degree) and 5+ years GMP experience, or Master of Science (STEM) with 3+ years in a cGMP laboratory (pharmaceutical CMO/CRO)
• Experience with analytical data review and documentation practices
• Working knowledge of analytical methods (HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry) and microbiology testing
• Working knowledge of GMP/GDP and laboratory systems
• Candidates must have current, valid authorization to work in the country where this role is located.

Preferred:

• Working knowledge of USP, ISO, FDA, and ICH guidelines
• Familiarity with LIMS
• Strong communication skills; solid organization and deadline management