Sr Data Reviewer

Position Overview

• Location Type: Remote
• Employment Type: Full Time
• Job Type: Sr Data Reviewer
• Division: Laboratory Services
• Company: PPD, part of Thermo Fisher Scientific

The Sr Data Reviewer is responsible for supporting laboratory teams, specifically the Cell and Molecular biology lab, to ensure the integrity and quality of laboratory and chromatographic data and reports. This role involves reviewing complex analytical data from pharmaceutical and biopharmaceutical compounds across various formulations and biological matrices. The ideal candidate will possess strong review experience, Cell & Molecular biology experience, and a desire to transition away from hands-on laboratory duties.

Requirements

• Thorough understanding of laboratory procedures.
• Reliable conduct of routine, nonroutine (method establishment), and complex analytical data review.
• Experience with pharmaceutical and biopharmaceutical compounds.
• Knowledge of various formulations and biological matrices.
• Understanding of method validation principles.
• Familiarity with Good Manufacturing Practices (GMP).
• Strong documentation practices.

Responsibilities

• Data Review: Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, client directives, and scientific soundness.
• Development Analyses: Reviews development analyses of non-routine projects.
• Method Validation: Performs analytical data review of method qualification, verification, and validations, interpreting the data for compliance and technical soundness.
• Protocol & Method Review: Performs reviews of routine and non-routine protocol and methods.
• Collaboration: Facilitates conversations with lab staff on best documentation practices and addressing quality findings.
• Quality Assurance: Ensures analyses are following validated or experimental analytical procedures, comparing results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP).

Salary

• Salary information is not provided in the original job description.

Application Instructions

• Application instructions are not provided in the original job description.