Senior Data Reviewer, Quality Control (2nd shift)
About The Position
Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing RNAi-based therapeutics for intractable diseases. The Senior Data Reviewer serves as a technical subject matter expert responsible for overseeing complex laboratory data review activities. This role is crucial for ensuring the accuracy, reliability, and inspection readiness of internal and external laboratory data by providing advanced expertise in data integrity, audit trail review, GMP compliance, and risk-based decision-making. The Senior Data Reviewer will lead complex investigations, drive continuous improvement, mentor junior staff, and collaborate cross-functionally to enhance compliant and efficient review practices. This position operates on a 2nd shift, from 1 pm to 11:30 pm, Monday through Thursday, and includes a 10% shift differential.
Requirements
- Bachelor’s degree in chemistry or (any STEM degree) and 8+ years of experience or master’s degree and 5+ years of experience 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 and experience with chemistry analytical methods such as HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry and microbiology testing.
Nice To Haves
- Working knowledge of USP, ISO, FDA and ICH guidelines
- Familiarity with laboratory information systems.
- 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.
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 all data and documentation are maintained in a state of 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
- Serve as a primary representative during regulatory inspections, client audits, and compliance assessments
- Assess compliance and data integrity risks, develop mitigation strategies, and drive corrective and preventive actions to reduce operational and regulatory risk
- Lead continuous improvement initiatives focused on strengthening data review effectiveness, inspection readiness, workflow efficiency, and digital enablement strategies
- Mentor and train Data Reviewers I and II; provide technical guidance and troubleshooting support
- Partner with leadership to ensure milestones, timelines, and compliance objectives are achieved
- Influence departmental procedures, review standards, and compliance strategies through technical expertise and risk-based decision-making
- Embrace statistical tools for trend analysis, system suitability trending, deviation investigations, and overall laboratory performance.
- Other duties as assigned
Benefits
- competitive salaries
- excellent benefit package
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What This Job Offers
Job Type
Full-time
Career Level
Senior
