Purpose

The QC Data Reviewer I review data from laboratory testing within a fast paced GMP environment to support one or more of the following areas: raw materials, in-process product, final bulk, stability, environmental monitoring, microbiology and or validation. Reviews data for compliance to SOP, protocol and GMP requirements. Works under the guidance of a supervisor but can manage time efficiently in achieving timely completion of assigned duties. Assists in review of data to support investigations.

Responsibilities

• Reviews data from laboratory testing to support product/material release
• Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements
• Understand, implements and maintains GMP with respect to laboratory records, procedures and systems in accordance with procedural requirements
• Accepts responsibility to complete assigned tasks as committed. Works with other to maintain a positive  atmosphere to accomplish business objectives
• Able to interpret and perform data review on results from complex lab tests with minimal error. ·
• Able to guide lab analysts on mitigation of documentation errors (Op note, aberrant peak forms...) ·
• Participatory in continuous improvement projects, and change request (CR Processes/Processing)
• Basic leadership of small projects and change management (i.e. annual logbook reconciliation/issuance, · archive process maintenance…)
• Review of raw data for non-routine studies where protocols are already written and approved.