Stability Analyst

Description

Job Summary: Responsible for performing, recording, and monitoring stability studies of raw materials, in-process products, and finished products, ensuring compliance with Good Laboratory Practices (GLP). Key Responsibilities: 1. Perform and record analytical stability testing 2. Conduct physicochemical analyses and technical documentation 3. Participate in investigations of out-of-specification results A pharmaceutical laboratory requires technologists or professionals in Chemistry or related sciences, with a minimum of 6 months’ experience for the position of **STABILITY ANALYST 2**, who will be responsible for performing, recording, and monitoring stability studies of raw materials, in-process products, and finished products, ensuring compliance with stability programs, internal procedures, and Good Laboratory Practices (GLP). This role ensures proper sample preparation, physicochemical analyses, 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 corresponding **analytical tests** at the time points defined for each study. * Record and report **analytical results** derived from stability testing. * Perform **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 working condition and report maintenance or calibration needs. * Notify **out-of-specification (OOS) results** and participate in technical investigations together 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 orderliness and cleanliness at the end of each workday. Employment Type: Full-time Work Location: On-site employment