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Quality Systems - Lims Developer / Implementation Manager / Testing Resume

PROFESSIONAL SUMMARY:

  • Confidential is an IT professional with over 30 years of experience in the design, installation, implementation, validation and support of Oracle and SQL Server based Laboratory Information Management Systems (LIMS).
  • Information Technology Project Manager with 10+ year’s industry experience and career progression from Applications Development to Project Management including experience with several iterations of the software development lifecycle SDLC using Structured Methodologies, including: Waterfall, Agile / SCRUM, and Incremental.
  • Experience includes managing, supporting, implementing software development projects involving 3rd party applications, Oracle, SQL based.
  • Possesses exceptional communication and presentation skills, as well as strong management, leadership and mentoring skills.

TECHNICAL SUMMARY:

  • Microsoft Office Suite
  • DEC VAX/ALPHA Servers
  • LIMS System Administration
  • Microsoft Windows Products
  • PC Based Servers
  • Project Management
  • Terminal Server/Citrix
  • PC Based Workstations
  • Quality Management
  • Visual Basic
  • Laboratory Instrumentation
  • Business Analyst
  • Various Web Browsers
  • RF Signal Generators
  • Validation Specialist
  • Lotus Notes
  • ISO / GAMP / SOX Auditor
  • Microsoft VISIO Technical
  • Oracle
  • Various LIMS Systems (Labware, StarLIMS, SQL LIMS, Labvantage)
  • SQL Server
  • Instrument interfacing SW
  • Microsoft Access
  • Windows Server
  • 2000/2003/2008
  • Microsoft Project
  • Dbase 4
  • Java (Basic Concepts)
  • MySQL
  • DOS
  • Loadrunner (Basic Concepts)
  • Novell
  • Microsoft Sharepoint
  • VMS
  • Plateau LMS
  • Agile / SCRUM Methodology
  • JIRA / Remedy

PROFESSIONAL EXPERIENCE:

Confidential

Quality Systems - LIMS Developer / Implementation Manager / Testing

Responsibilities:

  • Developed a formal method for system deployment of code updates, core application upgrades, and master data updates.
  • Produce System Standard Operating Procedures relevant to system functionality as well as business practices within the Confidential SeedHealth and Crop Protection organizations.
  • Validate core application upgrades, custom software configuration, hardware structure, and operating system upgrades relating to current industry standard guidelines as well as end user specifications.
  • Coordinate testing efforts of external systems interacting with core Labware LIMS application
  • Provide High Level Support (L3) to all Quality Platform Applications. Work with other internal divisions as well as external vendors to resolve issues.
  • Assist with Life Cycle Management tasks of all hardware, software, database, and connectivity components associated with Quality Systems.
  • Participated in efforts of the Teradata re-design of GQA Lab and Analytics Reporting (formally Business Objects / Business Warehouse system)

Testing / Validation - Microsoft Office Suite, Microsoft Windows Products, Various Web Browsers, Microsoft VISIO Technical, Microsoft Project, PC Based Servers, PC Based Workstations, Remedy, Microsoft Sharepoint, Citrix Presentation Server, SAP, Various Laboratory Instrumentation Systems, JIRA, Remedy, Agile / SCRUM Methodologies.

Confidential

Quality Systems - LIMS Validation Project Manager

Responsibilities:

  • Coordinated the validation process between the Software Vendor(s), Confidential Corporation, and third party contractors.
  • Evaluated prior validation efforts and performed Gap Analysis/Risk Assessment task to determine future validation requirements.
  • Published Validation Documentation corresponding to Corporate Validation guidelines.
  • Acted in a Facilitation capacity for process improvement using cross-functional implementation and validation teams to achieve strategic goals and objectives.

Technical Environment: Microsoft Office Suite, Microsoft Windows Products, Various Web Browsers, Microsoft VISIO Technical, Microsoft Project, PC Based Servers, PC Based Workstations, Plateau, Microsoft Sharepoint, Citrix Presentation Server.

Confidential

LIMS/IS Project Manager

Responsibilities:

  • Project Manager/System Analyst for a Capital Project involving the Installation, Implementation, Customization (according to Standardized Business Practices), Configuration and Validation of LabVantage Sapphire LIMS for 27 Manufacturing Facilities in North America.
  • Provide 24/7 Support to all End-Users at 27 Facilities in North America.
  • LIMS - Disaster Recovery Specialist. Participated in Disaster Recovery Exercises (LIMS) Installation at DR Hot Site and Updated Disaster Recovery Documentation on an ‘As Needed Basis’.
  • Responsible for Master Data Configuration of all LIMS related facilities.
  • Identified system issues / develop Traceability Matrix to formally track issue status. Work with Software Vendor to resolve issues. Validate / perform Regression Testing to verify system integrity.
  • Facilitated a Database Normalization Project. Identified the need to normalize the database schema within all tables of the RDBMS. Developed a matrix to identify the issues and executed the changes as needed.

Technical Environment: Microsoft Office Suite, Microsoft Windows Products, Various Web Browsers, Lotus Notes, Microsoft VISIO Technical, Microsoft Project, DEC VAX/ALPHA Servers, PC Based Servers, PC Based Workstations, RF Signal Generators

Confidential

Quality Auditor

Responsibilities:

  • Published Standard Operating Procedures for the execution of Quality Audits.
  • Effectively execute an audit plan, including the opening meeting, performing the audit, and the closing meeting using generally accepted auditing techniques and verifying, documenting, and communicating findings as appropriate for the audit.
  • Facilitate as a Lead Auditor on numerous audits for a Confidential - Confidential under Supplier, ISO, PDMA, and SOX guidelines - applying basic auditing tools and techniques, such as flowcharting, the concept of variation, observation techniques, and physical examination techniques.
  • Published Executive Summary Reports based on Audit data on an objective basis. Presented and verified nonconformance’s to the audited standard and evaluated the effectiveness of the follow-up/corrective action activities in an ethical and timely manner.

Technical Environment: Microsoft Office Suite, Microsoft Windows Products, Various Web Browsers, Lotus Notes, Microsoft Project.

Confidential

Validation Specialist

Responsibilities:

  • Coordinated the validation process between the vendor, Confidential, and third party contractors.
  • Evaluated prior validation efforts and performed Gap Analysis/Risk Assessment surveys to determine future validation requirements.
  • Published documentation to establish Corporation Validation guidelines.
  • Established IT Policies and Procedures for the Confidential Information Technology Division.
  • Accomplished business critical method development and process improvement. Acted in a Facilitation capacity for process improvement using cross-functional implementation and validation teams to achieve strategic goals and objectives.

Technical Environment: Microsoft Office Suite, Microsoft Windows Products, Various Web Browsers, Lotus Notes, Microsoft VISIO Technical, Microsoft Project, DEC VAX/ALPHA Servers, PC Based Servers, PC Based Workstations, RF Signal Generators

Confidential

LIMS/IS Project Manager

Responsibilities:

  • Software used for Project Management included Oracle Developer, Windows 2000 Terminal Services, Microsoft Office Suite, Microsoft Project, and VISIO Technical.
  • Prepared & Executed IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) Validation Documentation, and participated on the Validation Team to validate AB SQL*LIMS v4.0.
  • Coordinated SQL*LIMS to address issues involving 21CFR Part 11 - the FDA Guidelines on Electronic Signatures and Records.
  • Installed a Laboratory Computer System under capital budget allocations.
  • Supported Novell LAN, Windows NT, and Windows 2000 Systems with relation to the LIMS Project.
  • Identified system issues / develop Traceability Matrix to formally track issue status. Work with Software Vendor to resolve issues. Validate / perform Regression Testing to verify system integrity.
  • Facilitate the implementation of OS / LIMS System software patches through formal Change Management process.

Technical Environment: Microsoft Office Suite, Microsoft Windows Products, Various Web Browsers, Lotus Notes, Microsoft VISIO Technical, Microsoft Project, DEC VAX/ALPHA Servers, PC Based Servers, PC Based Workstations, RF Signal Generators

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