Overview
The Laboratory Technician – LC-MS / GC-MS (Genotoxic Impurity Routine Analysis) is responsible for performing routine analytical testing in support of release and stability studies within a GMP-regulated environment. The role focuses on the execution of LC-MS and GC-MS analyses for genotoxic impurity testing, including sample and solution preparation, instrument operation, data review, documentation, and routine instrument care. The position plays a key role in ensuring timely, accurate, and compliant delivery of analytical results while maintaining high standards of data integrity, laboratory organization, and regulatory compliance. The Laboratory Technician works closely with scientists, reviewers, and laboratory colleagues to support smooth daily operations, instrument reliability, and continuous improvement of routine analytical workflows.
Responsibilities
* Perform routine analytical testing for release and stability studies using LC-MS and/or GC-MS methods for genotoxic impurity analysis
* Prepare samples, standards, reagents, and mobile phases in accordance with approved methods and laboratory procedures
* Operate, monitor, and troubleshoot LC-MS and GC-MS systems to ensure smooth and efficient analytical execution
* Ensure accurate, complete, and timely documentation of all analytical activities in LIMS, Chromeleon, and paper-based records, in compliance with GMP and data integrity requirements
* Collaborate closely with scientists, reviewers, and laboratory team members to support daily laboratory operations and project timelines
* Archive raw data and analytical documentation in accordance with internal procedures and regulatory requirements
* Contribute to maintaining a clean, organized, and inspection-ready laboratory environment
* Support continuous improvement initiatives to enhance laboratory efficiency, data quality, and operational reliability
Qualifications
* Completed laboratory technician training (or equivalent scientific/technical education) in analytical chemistry, chemistry, or a related field or Bachelor degree in chemistry or analytical science
* Practical hands-on experience with LC-MS and/or GC-MS in a laboratory environment
* Experience in routine analytical testing is preferred, exposure to trace analysis or genotoxic impurity analysis is an advantage
* Familiarity with GMP-compliant laboratory work and documentation practices is a strong plus
* Experience with laboratory software such as LIMS and Chromeleon is an advantage
* Strong attention to detail and a high level of accuracy in data handling and documentation
* Good organizational skills and the ability to manage routine tasks in a structured and reliable manner
* A team-oriented mindset, with a willingness to learn, grow, and share knowledge with colleagues
* Fluency in English is required, German is an advantage
#J-18808-Ljbffr