Stability Technician
About this position
Responsibilities
• Assist in the development, validation, and transfer of stability testing programs, as directed by senior lab personnel.
• Document and record test results, observations, and data accurately and in a timely manner.
• Assist in conducting routine stability testing of raw materials, intermediates, and finished products under the supervision of senior team members.
• Prepare samples, reagents, and solutions for analysis, following established protocols and procedures.
• Support the execution of stability studies, including sample preparation, monitoring, and documentation.
• Support stability testing activities to assess the shelf-life and performance characteristics of products.
• Assist and perform basic calibration and maintenance of laboratory instruments and equipment, ensuring proper functionality and accuracy.
• Document and record test data, and assist in the preparation of reports.
• Follow standard operating procedures (SOPs) and safety protocols to maintain a safe and clean working environment.
• Maintain a clean and organized laboratory environment, adhering to safety guidelines.
• Follow established protocols and procedures to ensure accurate and reliable results.
• Stay updated with regulatory changes, the latest stability techniques and technologies through continuous learning and training opportunities.
• Collaborate closely with cross-functional teams, including Research & Development, Quality Assurance, and Manufacturing, to drive alignment, coordination, and shared responsibility for product development, quality, and continuous improvement initiatives.
• Contribute to continuous improvement initiatives within the lab, suggesting ideas and implementing best practices.
Requirements
• Knowledge of regulatory guidelines (e.g., FDA, EMA) and industry best practices related to analytical development and stability testing.
• Basic knowledge of laboratory safety practices and procedures.
• Knowledge in analytical techniques such as HPLC, GC, dissolution testing, and spectroscopy.
• Familiarity with statistical analysis software and data management systems.
• Familiarity with regulatory requirements and quality standards related to analytical development and stability testing is a plus.
• Good communication and interpersonal skills, with the ability to work effectively in a team environment.
• Good English communication skills, both written and verbal. Other languages are a plus.
• Excellent organizational and time management skills, with the ability to prioritize tasks.
• Strong attention to detail and the ability to follow instructions accurately.
• Good computer skills, including proficiency in MS Office applications.
• Enthusiasm for learning, adapt to changing priorities, and contribute to a positive and dynamic work culture.
• Desire to develop a career in analytical development and lab stability.