The Laboratory Information Management Systems (LIMS) is a critical repository of a host of information used by a variety of groups within Repertoire. That include Clinical Operations, Translational Research, Platform, CMC, Quality Systems and Automation teams.
What you will do:
In this role you will proactively assist in the maintenance and improvement of systems and procedures so the departments and laboratory functions can utilize the system as effectively and efficiently as possible. With a strong end-user focus and the skills required to communicate effectively with end users, IT and vendors, the LIMS Administrator will play an active role in maintaining a positive team environment across the LIMS user base. You will also identify and understand issues that may impact the day to day operations of the laboratory as well as be able to offer support and advice to both end users and leadership.
Your primary contribution will be to prioritize cross-departmental goals and ensure that the workflows and processes covered by the LIMS are serving the user base of the system efficiently.
- Manage and lead the initial implementation and validation of a Laboratory Information Management System (LIMS) system at Repertoire.
- Maintain and update the validated LIMS system, create new users, and be the primary support point person of the validated LIMS.
- Diagnose system issues and provide technical support to users in services, installations and training of the validated LIMS.
- Work with the software vendor to troubleshoot issues related to the validated LIMS access or performance and maintains the validated LIMS software to minimize downtime until solutions are reconciled.
- Gather feedback from users on new solutions required to support new use cases stemming from process changes and evolving research and build out proposals to address business gaps or improvement opportunities.
- Ensures that validated LIMS activities are conducted in compliance with current Repertoire Quality Management System requirements, all data integrity standards are maintained, and issues are mitigated in a timely manner. Communicates with Quality Assurance leadership when a quality issue with the validated LIMS is identified.
- Primary subject matter expert (SME) for the validated LIMS during audits and will ensure the audit readiness of the following: qualification documentation, user lists and privileges, and procedures.
- Recommends and/or implements system enhancements as needed to make the best use of the validated LIMS system and improve the end-user experience, be it through greater efficiencies within the system, interfaces with other equipment/applications, and/or electronic solutions to manual processes.
- Evaluates data generated and/or stored within the system to provide ad hoc and long-term reporting solutions that address business needs and identify process gaps that might otherwise go unnoticed.
- Contribute to and maintain SOPs and training materials
What you will bring to the role:
- Bachelor’s degree in life sciences or computer sciences/bioinformatics and 5+ years’ experience working with LIMS systems
- Proven track record of maintaining a validated LIMS system. Familiarity with validation and working in a controlled environment (e.g. GLP/GMP or CLIA)
- Strong analytical, communication and problem-solving skills
- Understanding of routine workflows in regulated laboratories
- Knowledge of QMS and QA operations
- Knowledge of clinical laboratory operation and information processing
- Good knowledge of typical lab systems and related Instrumentation
- Laboratory experience is a plus
- Systems integration experience is a plus