Quality-Focused LabWare LIMS Documentation Specialist
Resume:
Evelyn D Williams
Quality-focused professional
Lucama, North Carolina 27851, United States • 252-***-**** • *********@*******.*** • LinkedIn
Profile
Quality-focused professional with proven experience in general business operations, project management, and financial administration in pharmaceutical operations / manufacturing environments. History of success implementing superior customer service standards and effectively training individuals and teams. Records of improving efficiency, productivity, and profitability through automation and process improvement. Outstanding interpersonal and analytical skills. Core competencies include: Strategic Planning Quality Control Manufacturing Automation Process Improvement Client Relations Project Leadership Process Improvement Training and Development.
Areas of Expertise
• GLIMS (Global Laboratory Information Management System)
• Kneat
• MEDS
• File Surf
• SAP
• Laboratory Information Management System (LabWare LIMS)
• Gelco
• ProUnlimited
• MS Visio
• Ariba
• Microsoft Office
• Lotus 1-2-3
• TrackWise
• Data Entry 10,000+KP
• Application Lifecycle Management (ALM)
• TEAMS
• Zoom
• Develop/Configure Sample Workflows
• Instrument Module
• Batch Management
• Lot Management
• Stability
• LabVantage LIMS
• Star LIMS
Professional Experience
AAF, Kenly, NC, May 2026 to Jul 2026
Documentation Specialist
Created, reviewed, maintained, and stored essential organizational documents. Ensured files were accurate, accessible, and compliant with industry regulations. Duties included managing digital records, updating standard operating procedures (SOPs), and facilitating document control workflows across departments.
Pfizer, Seattle, WA, Aug 2024 to Jan 2026
LabWare LIMS Specialist (gLIMS version 8)
Maintained detailed descriptions of Quality business and user needs as well as documentation of steps in resolution process. Cultivated and maintained vendor relationships for error resolution and assisted with development of new programs for standalone, non-network applications.
•Responsible for migrating data from Labware LIMS V5 to Labware version 8 gLIMS
•Ensuring/verifying that the data works correctly in the new system
•Responsible for building and testing new LIMS builds and LIMS Master Data changes.
•Responsible for creating queries to retrieve LIMS data to support investigations and other business processes
•Review and approval of site documentation including but not limited to, change controls and SOPs in a timely manner
•Manage priorities to accomplish change activities/project deliverables; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines
•Reports issues and elevates them to appropriate management attention immediately
•Can independently manage workload based on priorities
•Identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
Pfizer, Sanford, NC, Apr 2023 to Jun 2024
LabWare LIMS Specialist (gLIMS version 8)
Maintained detailed descriptions of Quality business and user needs as well as documentation of steps in resolution process. Cultivated and maintained vendor relationships for error resolution and assisted with development of new programs for standalone, non-network applications.
•Responsible for migrating data from Labware LIMS V5 to Labware version 8 gLIMS
•Ensuring/verifying that the data works correctly in the new system.
•Responsible for building and testing new LIMS builds and LIMS Master Data changes.
•Responsible for creating queries to retrieve LIMS data to support investigations and other business processes
•Review and approval of site documentation including but not limited to, change controls and SOPs in a timely manner
•Manage priorities to accomplish change activities/project deliverables; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines
•Reports issues and elevates them to appropriate management attention immediately
•Can independently manage workload based on priorities
•Identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
Merck, Wilson, NC, Jun 2021 to Dec 2022
LabWare LIMS Specialist (gLIMS version 8)
Maintained detailed descriptions of Quality business and user needs as well as documentation of steps in resolution process. Cultivated and maintained vendor relationships for error resolution and assisted with development of new programs for standalone, non-network applications.
•While working for Merck, I helped as an Administrator for gLIMS. Also, during this project I helped with the implementation of the new Stability system, which they merged from STABLIMS to gLIMS. I helped with making sure the products merged correctly into the new system, if not I had to make sure that the corrections were made in a timely manner.
•Provided ongoing electronic support and maintenance activities such as product builds / modifications, LIMS printer maintenance, LIMS folders builds, ad hoc queries, crystal report builds/modifications, electronic data reporting, and interface maintenance.
•Assessed change control for changes affecting electronic systems. Conducted routine checks for login from SAP to ensure all samples were accounted for and discrepancies were resolved by manual SAP / electronic systems entry in a timely fashion.
•Made changes to SQL Queries when necessary. Made changes to dates to make sure the correct information pulled within a certain month. Added additional information to the query per request of management or individuals when requested.
•Facilitated building tests / calculations in electronic systems and verified accuracy through executed qualification protocols. Generated and updated electronic/standard forms.
•Authored and maintained appropriate SOPs relating to electronic systems as required (General use, activities, security, etc.) Worked on Quality information system projects.
•Generated stability protocols and Post Approval Stability Commitments and provided Regulatory Affairs Annual Reporting.
•Provided preliminary recommendations for quality issues identified and appropriateness of actions taken for resolution in relation to stability areas.
•Adhered to all applicable procedures, cGMPs, company policies and other quality/regulatory requirements.
NOVARTIS (formerly SANDOZ/EON Labs), Wilson, NC, Mar 2017 to Jan 2021
Analyst I, Quality Business Systems / Stability
Maintained detailed descriptions of Quality business and user needs as well as documentation of steps in resolution process. Cultivated and maintained vendor relationships for error resolution and assisted with development of new programs for standalone, non-network applications.
•While working for Novartis, I helped as an Administrator for LabWare LIMS. Helped with the implementation of the new Stability system. During this implementation I helped with the merging from their previous system (SSII) to LabWare LIMS. Had to make sure that the products merged correctly to the new system.
•Provided ongoing electronic support and maintenance activities such as product builds / modifications, LIMS printer maintenance, LIMS folders builds, ad hoc queries, crystal report builds/modifications, electronic data reporting, and interface maintenance.
•Assessed change control for changes affecting electronic systems. Conducted routine checks for login from SAP to ensure all samples were accounted for and discrepancies were resolved by manual SAP / electronic systems entry in a timely fashion.
•Facilitated building tests / calculations in electronic systems and verified accuracy through executed qualification protocols. Generated and updated electronic/standard forms.
•Authored and maintained appropriate SOPs relating to electronic systems as required (General use, activities, security, etc.) Worked on Quality information system projects.
•Generated stability protocols and Post Approval Stability Commitments and provided Regulatory Affairs Annual Reporting.
•Provided preliminary recommendations for quality issues identified and appropriateness of actions taken for resolution in relation to stability areas.
•Adhered to all applicable procedures, cGMPs, company policies and other quality/regulatory requirements.
Feb 2010 to Mar 2017
LIMS Technical Support Analyst
Assisted users with issues regarding performing functions in LIMS, clarifying business processes relating to LIMS, and troubleshooting LIMS Zebra printer issues.
•Administered LIMS user training and provided training updates based on trends and data observed in the system (such as closing lots or reporting requirements for individual types of samples).
•Assisted in resetting and acquiring passwords and access for users.
•Met all project timeline goals.
•Developed and use LIMS queries/reports to generate metrics and eliminate Control Center Status Sheets.
Sep 2009 to Jan 2010
Control Center Administrator
Provided support to the Quality Control Laboratory. Prepared kits for chemists to perform product testing. Entered samples into LIMS database system. Ordered office and lab supplies.
Oct 2002 to Sep 2009
Quality Control Administrative Assistant I
Provided operational / management and clerical support to the Director of Quality Control. Maintained office supplies. Composed, typed, and proofread letters, memoranda, reports, and other print material.
Education
American InterContinental University, Chicago, IL, Oct 2013 to Aug 2014
Master of Business Management, Specialization in Accounting
American InterContinental University, Chicago, IL, Jan 2005 to Jun 2013
Bachelor of Business Management
Links
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