Quality Control LIMS Senior Specialist
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
This position will be responsible for the operational support of the LIMS (Laboratory Information Management System). This task includes application development and support, system administration with a focus on the LIMS systems. The position focuses on optimal support for system users and Good Manufacturing Practice (GMP) compliance of the system. In this position, the practical expertise from the laboratory is used to generate ideal solutions for digital logging within the LIMS system.
- Implements program upgrades, reports problems, supports Laboratory, Production and Quality Assurance personnel with application usage.
- Creates and maintains application procedures and system configuration documents.
- Maintains stored data and compliance documentation for all related software programs including, validation protocols, critical system change requests, and system functional requirements.
- Works with subject matter experts (SMEs) to clarify and document user requirements.
- Manages application validation and change control activities.
- Performs and/or reviews and verifies data modification and change controls as requested by applications end users.
- Performs software validation/changes. Executes software validation documentation and writes, executes and reviews change control documentation
- Writes and/or reviews and verifies reports requested by QA, Technical Support and Operations.
- Reviews/approves software documentation prepared by LIMS personnel.
- Maintains, modifies/upgrades, and troubleshoots programs and upgrades, which includes but not limited to: creation/modification of product specifications, analyses, and calculations; systems problems as they occur; and Screen Maintenance
- Evaluates product enhancements and capabilities as required.
- Keep current of technologies, and technological advances associated with Labware LIMS programs.
- Bachelor of Science in Computer Science and/or Associates Degree in Life Sciences discipline.
- Advanced hands-on experience with LIMS software / system usage, and/or laboratory experience.
- Skilled handling of common software applications (MS Office) and a keen interest in working with computer-based systems are required, user and/or specialist knowledge of LIMS and other pharmaceutical/laboratory software (e.g. Documentum) are an advantage
- Serves as one of the “go to” persons to answer LIMS and TrackWise functionality and business process questions.
- Utilizes in-depth understanding of the limitations of the application and how it may be changed to assess issues and define solutions.
- Translates functional business requirements into technical requirements and specifications.
- Authors and reviews SOP’s.
- Analyzes and assesses business impact and urgency of incidents/problems affecting application availability, function and/or performance to develop work priorities.
- Resolves Application Incidents and Problems impacting local business operations according to business impact priority
- Troubleshoots system-related problems and works with IT to escalate issues to vendor Support.
- Tracks and documents incident and problem-solving actions and results through to completion.
- Knowledge of Good Manufacturing Processes (cGMP).
- Acquires and documents training on all laboratory general tasks and is capable of performing assigned test methods and using associated instrumentation.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Strong communication skills both verbal and written.
- Dependable and able to work well within a team.
- Champions change speaking positively to and about others in all situations
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.