Data Reviewer, Quality Control

Arrowhead Pharmaceuticals, Inc. • Verona, WI

55d

About The Position

The Data Reviewer is responsible for ensuring the completion, quality, and compliance of laboratory data and reports produced within the Quality Control (QC) team. This includes the technical review of analytical testing data and related notebooks, forms, logbooks, and more as specified by Standard Operating Procedures (SOPs). This position will evaluate data to ensure compliance with analytical methods, specifications, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) standards. This position will manage deadlines for review completion and aid in the organization and maintenance of data. The ideal candidate will have experience with analytical testing, either in performance or technical review.

Requirements

• Bachelor's degree in Chemistry (or related scientific field).
• 2+ years' relevant experience (pharmaceutical CMO/CRO).
• Knowledge of cGMP and cGLP guidelines for contract manufacturing and analytical laboratories and ICH/FDA guidance documents.
• 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

• Evaluate QC laboratory data for compliance with analytical methods, protocols, specifications, and SOPs.
• Review sample analysis results for completeness and accurate representation of the data and report findings.
• Communicate with QC laboratory staff to proactively address the quality of laboratory documentation.
• Prepare statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the project leader for correction.
• Conduct SOP review and writing as well as conducts consultations for quality records.
• Work cross-functionally to harmonize data review practices and produce a consistent product.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 501-1,000 employees