• Provided business guidance as LIMS subject matter expert to support application strategy and manages system issues/resolutions.

• Managed and prioritized system changes through master data creation/updates against business requirements to enable product creation, QC testing, product release and COA generation.

• Created, revised and maintained system related Standard Operating Procedures, Work Instructions and Protocols in the document management system, MasterControl.

• Initiated, managed, and pushed to closure system related change controls for both LabVantage and Sapio LIMS using the change management system, MasterControl.

• Drafted, documented, and executed validation deliverables that were required to implement and maintain the regulatory business needs.

• Led an agile/waterfall strategy for a large-scale multi-phase implementation of LabVantage QC LIMS that allowed the business users early system access while ongoing validation was being conducted.

• Led and managed multiple Sapio Exemplar LIMS projects to convert Next Generation Sequencing (NGS) LIMS processes from Workflows to ELN Notebooks.

• Prepared and drafted future system capabilities into a chronological application road map.

• Established multiple role/access-based training materials and SOPs supporting the use and administration of the LabVantage LIMS.

• Delivered training to all QC, QA, Manufacturing users and new LIMS administrators on use of the LIMS.

• Provided primary bi-coastal end user system support, error troubleshooting, user account management.

• Mentored junior and senior personnel on the use and administration of LabVantage and Sapio LIMS.

• Completed assessments documenting the risks associated with computer systems within the QC department to support the validation lifecycle process.

• Created/updated COA & COT report templates using JasperSoft Report Developer software, report label templates using Bartender and the associated LIMS master data to facilitate report generation and label printing.

• Supported, administered, and developed functionality for Laboratory Information Management System (LIMS) and associated applications.

• Performed master data configuration of LIMS system and integration of laboratory equipment

• Collaborated with internal teams to design/create new master data builds as necessary.

• Provided primary technical support for end users of LIMS in a GxP and R&D environment.

• Created system documentations such as Standard Operating Procedures and validation documents (URS, FRS, IQ/OQ/PQ protocols)

• Lead projects to continually enhance, update and troubleshoot the system, increasing efficiency and data integrity throughout the Quality control testing processes through the completion of ~80+ change control processes annually

• Implement IT changes and verify the correctness/completeness of configuration by writing and executing test scripts then executing stress tests/validation of static data

• Provide LIMS support to 150+ users, through user training, the modification of user accounts, troubleshooting of ~200 LIMS issues annually, and the escalation to IT of any issues that cannot be resolved as an Admin

• Manage 150+ QC Microbiology Environmental/Utilities Monitoring programs and ensure samples are generated in the LIMS system to support routine manufacturing activities and any required facilities/utilities release testing

• Create, modify and maintain master data within LabWare LIMS through collaboration with the business/end users to understand processes, establish deployment objectives, identify data and design system layout

• Continually enhance, update and troubleshoot the system, increasing efficiency and data integrity throughout the Quality control testing processes through the completion of ~80+ change control processes annually

• Implement IT changes and verify the correctness/completeness of configuration by writing and executing test scripts then executing stress tests/validation of static data

• Provide LIMS support to 150+ users, through user training, the modification of user accounts, troubleshooting of ~200 LIMS issues annually, and the escalation to IT of any issues that cannot be resolved as an Admin

• Manage 150+ QC Microbiology Environmental/Utilities Monitoring programs and ensure samples are generated in the LIMS system to support routine manufacturing activities and any required facilities/utilities release testing

• Support the timely return of manufacturing facilities/utilities to GMP status through the coordination of, on average 8, out of service/shutdown activities per month