Data Reviewer, Quality Control

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefit package

Job summary

Arrowhead Pharmaceuticals is seeking a Data Reviewer in Madison, WI. The position involves technical review of laboratory data to ensure compliance with analytical methods and data integrity standards. The Data Reviewer will work independently to evaluate discrepancies and support continuous improvement initiatives.

Candidates should possess a relevant degree and 3-5 years of experience in a GMP laboratory. This role offers competitive salaries and benefits.

Qualifications

• 5+ years of GMP experience with a Bachelor's degree, or 3 years with a Master's.
• Experience in analytical data review and documentation.
• Knowledge of laboratory systems and software.

Responsibilities

• Perform independent technical reviews of data and documentation.
• Evaluate data for accuracy and compliance with GMP.
• Support audit readiness and participate in inspections.

Skills

Analytical data review

GMP compliance

Communication skills

Data integrity

Education

Bachelor’s degree in chemistry or STEM

Master of Science in STEM

Tools

HPLC

GC

LC-MS

NMR

FTIR

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

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.

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.

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.