Job Description:
- 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 Administrators in, 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.
- This role will support the creation and updating of master data to support the site transition to toa new ERP. Translation of data from existing documents to the electronic system for use in production and QC.
- Ensure site on-time implementation of new shift system (ERP) activities through support of master data configuration and data migration and SOP revisions.
- Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability and R&D operations.
- Provide first level diagnostic of incidents and support business users, IS LIMS Administrator and Support Centre 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.
- 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.
- Ensure that the LIMS complies with all relevant regulatory standards.
- Working knowledge of aseptic processes, biology, chemistry, life sciences.
- Knowledge of cGMPs and regulatory requirements with Strong analytical & balanced decision-making skills Good GMP documentation.
- HS Diploma.
- Must have 1+ years of experience in use and administration of Lab Ware LIMS specifically creation of product specs, sample plans and item codes.
- 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.
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