Data Reviewer, Quality Control (Verona, WI)

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Quick Summary

Overview

function googleTranslateElementInit() { new google.translate.TranslateElement({pageLanguage: 'en'}, 'google_translate_element'); } Data Reviewer, Quality Control (Verona, WI)…

Key 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.

Requirements Summary

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

Technical Tools

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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.

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.

Requirements:

Bachelor’s degree in Chemistry (or related scientific field) with 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.

Preferred:

Language Skills: Ability to read, analyze and interpret SOPs, test methods, procedural guides and associated technical documents. Ability to write in a clear and concise manner. Ability to effectively present information and respond to questions from management, peers and colleagues.
Mathematical Skills: Ability to perform complex math functions, compute ratios, rate, and percent. Ability to draw and interpret graphs and charts.
Reasoning Skills: Ability to solve practical problems and interpret a variety of instructions furnished in written, oral, diagram or schedule form.
Other Skills and Abilities: Ability to work with people at various levels of the organization. Basic knowledge of computers and PC’s. Ability to use windows-based software including MS Office and chromatography data collection software. Basic knowledge of laboratory equipment, procedures, and analytical testing.

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