***Due to client requirements this role is only open to USC or GC candidates***
Job Summary:
Position Summary:
The Lab Information Management System [LIMS] Business Administrator is essential to Quality Operations at the Swiftwater site for supporting the maintenance and improvement of the LIMS system.
Maintenance support will include supporting Business and IS LIMS Administrators in report design and build, updating master data for new and existing products, updating master data for new and existing analysis, maintaining system documentation, and providing ad hoc support to other departments. The position is expected to provide leadership to support system evolution and continuous improvement, and to support laboratory informatics needs.
Support the creation of New Master Data for new LabWare System build for EM ONE LIMS Global System. Translation of data form existing electronic sytem for use in mass upload tool and configuration
Position Responsibilities:
- Ensure site on-time implementation of OneLIMS EM activities through support of requirements definition, functional design, master data configuration and data migration, system validation, SOP revisions and development of end-user training.
- Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability and R&D operations
- Support business and Global IS LIMS Administrator in the creation, validation and maintenance of reports, calculations, queries
- Provide first level diagnostic of incidents and support business users, IS LIMS Administrator and Support Center in the management and timely resolution of technical
- Responsible for the master data management process including the updating of specifications and supporting the approval process
- Manage Global System update and changes which may include new modules and workflow changes
- Configure and Maintain instrument interfaces to Laboratory equipment
- Support the business and IS LIMS Administrator in the definition, approval and validation of new business requirements
- Ensure that the LIMS complies with all relevant regulatory standards
- Support the business in the creation and updating of training materials as changes to system occur
Technical competencies and soft skills:
Working knowledge of aseptic processes, biology, chemistry, life sciences with strong supervisory skills
Knowledge of cGMPs and regulatory requirements with Strong analytical & balanced decision-making skills
Basic Requirements:
3+ years of experience in use and administration of a LabWare LIMS including LIMS Basic
- Strong working knowledge of laboratory processes including cGMP's in a pharmaceutical environment
- Experience in system testing, validation, and master data management
- Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment
- Excellent written and verbal communications skills and the ability to lead and participate in teams
- Experience or familiarity of the Laboratory Environment
Preferred Requirements
- Experience with other systems (E.g. Laboratory instrument control and acquisition systems, Empower, Crystal Reports, NuGenesis, TrackWise, SAP)
- Experience with SQL and database structures
- Strong Project Management Skills
About Matlen Silver
Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works.
Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: info@matlensilver.com // 908-393-8600