Data Reviewer, Quality Control
Arrowhead Pharmaceuticals
Summary
The Data Reviewer independently performs technical review of laboratory data and documentation to ensure compliance with analytical methods, specifications, GMP/GDP requirements, and data integrity standards. This role exercises independent judgment in evaluating data quality, identifying discrepancies, and resolving routine to moderately complex compliance issues. The Data Reviewer supports inspection readiness activities, contributes to continuous improvement initiatives, and serves as a technical resource to junior team members.
Job description
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
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
Preferred
- 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
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
- 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
Benefits
- Competitive salaries
- Excellent benefit package
Company overview
Arrowhead Pharmaceuticals, Inc. is a publicly traded biotechnology company headquartered in Pasadena, California, specializing in the development of gene silencing therapeutics through RNA interference (RNAi) technology. Founded in 2004 and listed on Nasdaq under the ticker ARWR, the company focuses on treating intractable diseases by silencing disease-causing genes. Arrowhead's innovative TRiM (Targeted RNAi Molecule) platform enables precise targeting of specific messenger RNAs to reduce production of proteins associated with various conditions. The company's pipeline includes treatments for hepatitis B, liver diseases associated with alpha 1-antitrypsin deficiency, cardiovascular diseases, hypertriglyceridemia, and other metabolic disorders. With approximately 609 employees, Arrowhead has established significant partnerships with major pharmaceutical companies including Janssen, Amgen, and Takeda, demonstrating the commercial potential of its RNAi platform. The company recently achieved FDA approval for its therapy targeting Familial Chylomicronemia Syndrome (FCS), marking a significant milestone in its mission to revolutionize treatment approaches for challenging diseases.