Senior Data Reviewer, Quality Control (2nd shift)

Scorpion Therapeutics; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Data Reviewer to oversee complex laboratory data review activities, ensuring data integrity, audit trails, and GMP compliance across internal and CDMO datasets, with a focus on inspection readiness. The role involves leading investigations, CAPA, and cross-functional collaboration to mitigate data integrity risks.

The candidate will mentor junior staff, review method validation data, and drive continuous improvement in data review processes and digital

Qualifications

• Bachelor’s degree in chemistry (or any STEM) with 8+ years’ experience, or master’s degree with 5+ years in a cGMP laboratory (pharmaceutical CMO/CRO)
• Strong experience with analytical methods + data review + audit trail review
• Deep knowledge of GMP, data integrity, and regulatory expectations
• Working knowledge of analytical methods: HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry, and microbiology testing

Responsibilities

• Perform advanced technical review of internal data and external CDMO datasets for compliance with specifications, GDP, and data integrity requirements
• Serve as SME for data integrity, audit trail review, and documentation standards
• Lead complex data review investigations, compliance assessments, and root cause evaluations for deviations and data integrity concerns
• Ensure data and documentation are maintained in inspection readiness
• Review/approve routine release and stability data, method validation data and reports, cleaning data, IPC data, and critical manufacturing support records
• Provide oversight of external laboratory/CDMO data quality and compliance
• Represent the company during regulatory inspections and client audits
• Assess compliance and data integrity risks; develop mitigation strategies and drive CAPA
• Lead continuous improvement initiatives for data review effectiveness, inspection readiness, workflow efficiency, and digital enablement
• Mentor and train Data Reviewers I and II; provide technical guidance
• Partner with leadership to achieve milestones, timelines, and compliance objectives
• Use statistical tools for trend analysis, system suitability trending, deviation investigations, and lab performance

Skills

Data review

GMP compliance

Data integrity

Audit trail review

Regulatory knowledge

Analytical methods knowledge

Education

Bachelor’s degree in chemistry or STEM

Master’s degree (related field)

Job description

The Position

The Senior Data Reviewer is a technical subject matter expert responsible for oversight of complex laboratory data review activities supporting operations. Provides advanced expertise in data integrity, audit trail review, GMP compliance, and risk-based decision-making to ensure accurate, reliable, and inspection-ready internal and external laboratory data. Leads complex investigations, drives continuous improvement, mentors junior staff, and partners cross-functionally.

Responsibilities

• Perform advanced technical review of internal data and external CDMO datasets for compliance with specifications, GDP, and data integrity requirements
• Serve as SME for data integrity, audit trail review, and documentation standards
• Lead complex data review investigations, compliance assessments, and root cause evaluations for deviations, discrepancies, and data integrity concerns
• Ensure data and documentation are maintained in inspection readiness
• Review/approve routine release and stability data, method validation data and reports, cleaning data, IPC data, and critical manufacturing support records
• Provide oversight of external laboratory/CDMO data quality and compliance
• Represent the company during regulatory inspections and client audits
• Assess compliance and data integrity risks; develop mitigation strategies and drive CAPA
• Lead continuous improvement initiatives for data review effectiveness, inspection readiness, workflow efficiency, and digital enablement
• Mentor and train Data Reviewers I and II; provide technical guidance
• Partner with leadership to achieve milestones, timelines, and compliance objectives
• Use statistical tools for trend analysis, system suitability trending, deviation investigations, and lab performance

Requirements

• Bachelor’s degree in chemistry (or any STEM) with 8+ years’ experience, or master’s degree with 5+ years in a cGMP laboratory (pharmaceutical CMO/CRO)
• Strong experience with analytical methods + data review + audit trail review
• Deep knowledge of GMP, data integrity, and regulatory expectations
• Working knowledge of analytical methods: HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry, and microbiology testing

Preferred

• Working knowledge of USP, ISO, FDA, and ICH guidelines
• Familiarity with laboratory information systems
• Strong verbal and written communication; matrix collaboration
• Organizational skills; ability to adapt to changing priorities