# Kersha E.

> Informatics Engineerer at Astrix

Location: Hayward, California, United States
Profile: https://flows.cv/kersha

Laboratory Information Management System Professional with 16+ years of biotech experience, 8+ of which include QC LIMS/eLN systems, building capability roadmaps, NextGen Sequencing, developing a validation/change management cadence to support the release of large features to minimize the impact on business resources and supporting all changes to these GxP systems via change control.

## Work Experience
### Informatics Engineer @ Astrix
Jan 2024 – Present | San Francisco Bay Area

### Sr. LIMS Specialist / Manager @ Gritstone bio
Jan 2022 – Jan 2024 | Pleasanton, California, United States
•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.

### LIMS Specialist @ Gritstone bio
Jan 2020 – Jan 2022
•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)

### QC Lead (LIMS Admin) @ Grifols
Jan 2019 – Jan 2020
•	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

### QC Sr. Analyst (LIMS Admin) @ Grifols
Jan 2015 – Jan 2019
•	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

### Senior QC Analyst @ Grifols
Jan 2014 – Jan 2015
•	Provided leadership to the Microbiology group and developed 4 analysts through mentorship and training, to guarantee that all work was carried out in accordance with the relevant regulatory requirements
•	Increased cross-functionality of the group by 20% by delivering pertinent Quality System, cGMP and more complex microbial assay methods training, trainings which were delivered to multiple analysts across 20 plus methods
•	Efficiently managed Deviation events by serving as initiator, owner and lead investigator of ~90% of the group’s Deviations to drive investigations, closure of the events and any resulting CAPAs
•	Established and maintained an open line of communication with QA, facilities and area managers to proficiently coordinate release requirements and schedule testing of all quarantined manufacturing areas and systems
•	Wrote and implemented changes to controlled documents and performed both compliance and technical review of documents to provide current/up-to-date requirements as industry regulations and standards are revised
•	Supported environmental/utilities monitoring, microbial identification and product release through the execution of advanced QC Microbiology Standard Operating Procedures (SOPs), review of testing data.

### QC Analyst @ Grifols
Jan 2012 – Jan 2014
•	Assured the Manufacturing areas maintained a GMP status through the performance of routine Environmental and Utilities Monitoring, which include the monitoring the quality of the air, water, and compressed air/gas systems
•	Expedited the completion of microbial assays for in-process and final products to facilitate timely release of manufactured products
•	Delivered Technical Training (On-the-job Training) to Analysts to ensure compliance with all SOPs and specifications

### Quality Control Associate II @ Abbott Diagnostics Santa Clara, CA
Jan 2010 – Jan 2012
•	Guaranteed the timely completion of Functional Product Release Testing, chemistry (PH, Osmolality and Conductivity) and Functional Stability Testing to provide reagent manufacturing and On-Market product support
•	Identified problems or potential problems of moderate complexity, initiated failure analyses, and offered any recommendations for corrective actions and/or preliminary investigations to support compliance, cGMP and cGLP
•	Trained personnel in the use of the LIMS database and basic/specialized Hematology and Chemistry instruments to guarantee proper utilization

### Lab Technician @ Terumo
Jan 2007 – Jan 2010 | Fremont, CA
•	Executed validation testing of the Tacura Console, its processes (whole blood and double red blood cell collection) and its disposable kits prior to all clinical trials in preparation for FDA approval submission
•	Analyzed blood products using Abbott Cell-Dyn CBC, Horiba ABXMicros, Spectrophotometer for hemolysis determination, spun hematocrit, and hemocue hemoglobin measurements as part of the equipment validation process
•	Facilitated the validation process by generating and maintaining standard operating procedures, originating and executing protocols, and maintaining Microsoft Excel database spreadsheets

### Medical Laboratory Technician Intern @ Schneider Regional Medical Center
Jan 2007 – Jan 2007 | St. Thomas, VI
•	Performed and assisted various microbial (urine, stool, blood, vaginal, etc) and serological (hepatitis, syphilis, screening for streptococcal infections and thyroid related disorders) tests. 
•	Supported the Hematology and Blood Banking departments.

### Resident Assistant @ University of the Virgin Islands
Jan 2004 – Jan 2006

### National Science Foundation Scholar (Research Assistant) @ University of the Virgin Islands
Jan 2004 – Jan 2004 | St. Thomas, VI
•	Successfully dissected and collected extra cellular and intracellular recordings of the Stomatogastric Nervous System, under the mentorship of a Neurobiologist studying the effects of temperature acclimation on the motor patterns of the Caribbean Spiny Lobster.

### National Science Foundation Scholar (Research Assistant) @ Texas A&M University-Corpus Christi
Jan 2005 – Jan 2005
•	Assessed the efficacy of herbal extracts on various bacterial strains through the implementation of the Kirby-Bauer antibiotic sensitivity tests and Minimum Inhibitory Concentration tests.

### National Science Foundation Scholar (Research Assistant) @ University of the Virgin Islands
Jan 2003 – Jan 2003 | St. Thomas, VI
•	Successfully dissected and collected extra cellular and intracellular recordings of the Stomatogastric Nervous System, under the mentorship of a Neurobiologist studying the effects of temperature acclimation on the motor patterns of the Caribbean Spiny Lobster.


## Education
### Bachelor of Science in Biology
University of the Virgin Islands

### Diploma in High School/Secondary Diplomas and Certificates
Ivanna Eudora Kean High School


## Contact & Social
- LinkedIn: https://linkedin.com/in/kersha-e-b63abb2

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Source: https://flows.cv/kersha
JSON Resume: https://flows.cv/kersha/resume.json
Last updated: 2026-04-11