Chemist/Scientist - Analytical Technical Steward
The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both company and external requirements and is executed consistently to predetermined standards.
The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this.
Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support.