Purpose

Performs laboratory testing within a GMP environment in support of one or more of the following areas; raw materials, in-process product, finished product, stability, and/or validation. Uses scientific education and/or experiences to generate results in accordance with GMP/procedural requirements and scientific principles. Interprets data output to determine conformance with product specifications. Reviews and verifies data generated by others to determine conformance with product specifications. Understands internal business process, to make appropriate prioritization of their assigned work duties. Has experience and command of multiple laboratory techniques to perform them with minimal error. Can train other laboratory personnel on any technique they currently have in their training matrix.

Responsibilities

• Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Proposes and implements changes to maintain procedural requirements.
• Performs analytical test methods as written to support product/material release with minimal error.
• Proposes and implements changes to improve laboratory techniques and methodology.
• Can independently troubleshoot and resolve analytical techniques and instrument issues.
• Interprets experimental data for conformance with product/material specifications.
• Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles.
• Initiates appropriate exception documents in accordance with procedural requirements.
• Implements and ensures improvement ideas are completed to facilitate team objectives.
• Proposes and implements scientific protocols to determine exception event cause.