Arrowhead Pharmaceuticals
Data Reviewer, Analytical Development
Verona, Wisconsin, United States
Sponsorship not specified$80k-$90kDetected 7 days ago
GMPFDA RegulatoryResearchMass SpectrometryAnimal StudiesCommunicationOrganizational Skills
About the role
- This role exercises independent judgment in evaluating data quality, identifying discrepancies, and resolving routine to moderately complex compliance issues.
Responsibilities
- Perform independent technical review of internal data and external laboratory data
- Independently evaluate, investigate, and document discrepancies, atypical results, and documentation inconsistencies to determine impact and ensure appropriate resolution
- 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
- 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
- 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.
- Candidates must have current, valid authorization to work in the country where this role is located.
Skills
- Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
- Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
Compensation
- Wisconsin pay range
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This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.