Job Description

Position Overview

• Location Type: Remote
• Employment Type: Full Time
• Job Type: Data Reviewer
• Division: Laboratory Services

Description: The Data Reviewer role supports our Laboratory teams, specifically the Cell and Molecular biology lab, ensuring the integrity and quality of laboratory and chromatographic data, protocols, and reports. The role focuses on reviewing data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Documentation Practice (GDP). This position is ideal for someone with strong review experience and Cell & Molecular biology background seeking a transition away from hands-on lab duties.

Requirements

• Strong review experience
• Cell & Molecular biology experience
• Knowledge of analytical methods
• Understanding of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practice (GDP)

Responsibilities

• Ensures the quality of laboratory data and reports.
• Reviews analytical data, related notebooks, and sample results for scientific soundness, completeness, accurate representation of the data, and final reported results.
• Evaluates data to ensure compliance with analytical methods, client criteria, GLP, GMP, and GDP.
• Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner.
• Communicates with laboratory staff to proactively address the quality of laboratory documentation.
• Prepares QC statements noting deficiencies with the analytical data set or notebooks.
• Reports deficiencies to the project leader for correction.
• Facilitates in conversations with lab staff on best documentation practices and addressing quality findings.
• Advocates for quality and review process changes.

Salary

• (Salary information is missing)

Application Instructions

• (Application instructions are missing)

Company Information

PPD, part of Thermo Fisher Scientific, provides clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research. Our Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.