LIMS Professional experienced in supporting GMP production environments for the QC pharmaceutical industry. Skilled in creating and maintaining/supporting Static Data, Batch Records, and performing Data Migration activities. Proficient in Confidential ’s LIMS Basic Programming Language. Familiar with Confidential ’s Business Rules, Event Triggers and Automation Scripts, as well as system tables. Have worked with Confidential modules and Electronic Laboratory Notebook. Proficient in SQL and have performed various database - related activities. Have worked with 21 CFR Part 11 compliant systems and understand complex laboratory processes. Have installed and maintained laboratory sensors for monitoring laboratory environments and equipment. Recognized for outstanding customer service. Dedicated worker with strong communication skills, both written and verbal
INFORMATICS TOOLS: LIMS (Versions 5 and 6), Confidential (Versions 2 and 8), Sequencher, AgileBio Confidential (Version 5.23).
PROGRAMMING LANGUAGES: C, C++, Perl, Java, Unix Scripts, some Python.
SOFTWARE TOOLS: TrackWise, InfoMaker, Crystal Reports, Mantis, ALM, SharePoint.
- Supported the company’s Confidential LIMS and ELN software.
- Responsible for LIMS and ELN support for research and development as well as production.
- Worked with LIMS vendor and supported Production for GMP.
- Managed instrument monitoring and integration.
- Supported users in San Diego and Shanghai laboratories and worked with Chinese IT group.
- Involved in creation of site-specific and global SOPs and Work Instructions, and was instrumental in creating alerts management process.
- Have created training materials and conducted training.
- Worked with a major pharmaceutical manufacturing client.
- Performed Confidential LIMS Master Data configurations and technical testing.
- Managed Go-Live events and served as work cell lead.
- Worked closely with site managers on converting from paper-based systems to LIMS.
- Was actively involved with mentoring and training up and coming LIMS professionals.
- Have managed LIMS team members and conducted interviews.
- Established the company’s LIMS Technical Group.
- Began working with the group on learning .NET programming and designing and implementing internal programming projects.
- Worked at client sites and performed static data loading activities.
- Wrote code in Confidential ’s LIMS Basic, reviewed data loads, and managed Junior Consultants.
- Worked as a code troubleshooter andbuilt LIMS objects in Confidential .
- Wrote Confidential reports in Crystal Reports.
- Participated in design process and performed training for users.
- Also wrote code in Perl to supplement data review and master data loading processes.
- Created and maintained LIMS user accounts. Set up Projects, created Product Specifications and built Analyses.
- Created Item Codes.
- Executed tests to verify limits. Migrated from DEV to PROD. Activated Confidential objects and closed out tickets.
- Wrote scripts to automate various processes used in data loading. During the transition from the company’s Confidential LIMS to Confidential LIMS, created new Analyses and Products and routed approvals to QA.
- Provided support to Confidential Idec’s Confidential LIMS user community, taking ownership of problems, tracking down the issues, and deploying the solution into Production.
- As requested, trained users on Confidential, demonstrating how Workflows are created from Analyses and Result Templates up to the final build (these users were usually involved in creating In Process Specs, yet initially had limited knowledge of the workings of Confidential