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Senior Data Reviewer, Quality Control
Job in
Madison, Dane County, Wisconsin, 53774, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-08-30
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Data Analyst, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
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 related to deviations, discrepancies, and data integrity concerns
- Ensure data and documentation are maintained in inspection readiness
- Review and approve routine release and stability data, method validation data and report, 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, client audits, and compliance assessments
- Assess compliance and data integrity risks; develop mitigation strategies; drive CAPA
- Lead continuous improvement (data review effectiveness, inspection readiness, workflow efficiency, digital enablement)
- Mentor/train Data Reviewers I and II; provide technical guidance and troubleshooting
- Partner with leadership to meet milestones, timelines, and compliance objectives
- Influence procedures, review standards, and compliance strategies using technical expertise and risk-based decisions
- Use statistical tools for trend analysis and system suitability trending
- Other duties as assigned
- Bachelor’s degree in chemistry or any STEM degree + 8+ years, or master’s degree + 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
- Experience with HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry, and microbiology testing
- Working knowledge of USP, ISO, FDA, and ICH guidelines
- Familiarity with laboratory information systems
- Strong verbal/written communication; ability to work in a matrix environment
- Solid organizational skills; ability to adapt to changing priorities
Wisconsin pay range: $100,000 USD - $110,000 USD
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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