Stability Analyst

Description

Position Summary: A professional responsible for executing and monitoring stability studies of pharmaceutical products, ensuring compliance with procedures and Good Laboratory Practices. Key Highlights: 1. Execution of stability studies for raw materials and products 2. Physicochemical analysis and OOS result management 3. Compliance with Good Laboratory Practices A pharmaceutical laboratory requires technicians or professionals in Chemistry or related sciences, with a minimum of 6 months of experience for the position of **STABILITY ANALYST 2**, who will be responsible for executing, recording, and monitoring stability studies for raw materials, in-process products, and finished products, ensuring compliance with stability programs, internal procedures, and Good Laboratory Practices. This role ensures proper sample preparation, physicochemical analysis, documentation, and result traceability, as well as supporting investigations related to deviations or out-of-specification results. **RESPONSIBILITIES:** * Perform **sample entry and withdrawal** from stability chambers or rooms. * Execute the **analytical assays** corresponding to the time points defined in each study. * Record and report the **analytical results** derived from stability assays. * Conduct **physicochemical analyses** according to established procedures (e.g., density, pH, viscosity, moisture content, etc., as applicable). * Support the **preparation of solutions and samples** for instrumental analysis. * Perform **verification of instruments or equipment** assigned to the studies. * Maintain laboratory **equipment, instruments, and materials** in good condition and report maintenance or calibration needs. * Notify **out-of-specification (OOS) results** and participate in technical investigations jointly with the Quality Control department. * Comply with and enforce **Good Laboratory Practices (GLP)** and applicable procedures for the area. * Complete **technical documentation** for analyses and stability studies, ensuring traceability and accuracy. * Maintain **confidentiality** of obtained results. * Support the updating of **procedures and specifications** related to stability studies. * Report requirements for reagents, standards, columns, and other consumables needed for analyses. * Use assigned reagents, standards, and other materials efficiently. * Contribute to laboratory order and cleanliness at the end of each workday. Employment Type: Full-time Work Location: On-site employment