Data Reviewer, Quality Control
About The Position
Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing medicines that treat intractable diseases by silencing the genes that cause them. Utilizing a broad portfolio of RNA chemistries and efficient delivery methods, Arrowhead therapies activate the RNA interference mechanism for rapid, deep, and durable knockdown of target genes. The company's RNAi-based therapeutics harness this natural gene silencing pathway. Arrowhead concentrates on developing innovative drugs for genetic diseases, often characterized by the overproduction of disease-related proteins. Their versatile RNAi technologies have the potential to address conditions across virtually any therapeutic area and target diseases not addressable by small molecules and biologics. Arrowhead is a leader in applying RNAi to diseases beyond the liver, with a clinical pipeline targeting liver and lung diseases and a promising preclinical pipeline. The Data Reviewer role involves independently conducting technical reviews of laboratory data and documentation to ensure adherence to analytical methods, specifications, GMP/GDP requirements, and data integrity standards. This position requires independent judgment in assessing data quality, identifying discrepancies, and resolving compliance issues of varying complexity. The Data Reviewer will also support inspection readiness, contribute to continuous improvement efforts, and act as a technical resource for junior team members.
Requirements
- Bachelor’s degree in chemistry or (any STEM degree) and 5+ years GMP experience, or a Master of Science (STEM degree) 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
Nice To Haves
- 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.
Responsibilities
- Perform independent technical review of internal data and external laboratory data
- Evaluate data for accuracy, completeness, and compliance with GMP and specifications
- Independently evaluate, 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 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
Benefits
- competitive salaries
- excellent benefit package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
