Kenneth Serna Email & Phone Number

College Station, Tx, Us

South Plainfield, New Jersey, Us

• Provide technology leadership to ensure high quality IT systems support and solutions to ensure smooth operation of quality and operations business functions.• Provide hands on expertise in validation, configuring, implementing and supporting IT initiatives such as LabVantage LIMS, Empower Upgrade from Empower 3 Build 1467 to Empower 3.7 and Veeva QMS Vault.• Implement various IT initiatives for quality and operations business functions, including monitoring of and leading any CFR Part 11 compliance initiatives.• Serve as Administrator for local Quality and Operations Systems, including establishing access levels, passwords, and troubleshooting systems/software as required.• Maintain oversight, lead and coordination of activities to support Computer Systems Validation Master Plan.• Develop validation plans, user requirement specifications, functional requirement specification, traceability matrix, IQ/OQ/PQ's and validation summary reports for various software solutions• Assess, determine validation requirements and provide approval for change controls for any requested changes to validated software systems.• Built strong partnerships with clients and vendors.

Gaithersburg, Maryland, Us

• Served as functional resource and subject matter specialist for Veeva Regulatory Information Management System (RIM), Lorenz DocuBridge and Schlafender Hase's Text Verification Tool.• Determined methods and procedures on new assignments, utilizing business process modeling, data modeling and analysis.• Partnered with assigned client(s) to identify and evaluate systems and procedures for business solutions.• Built strong partnerships with clients and vendors.• Participated in projects with varying levels of complexity: identifies, manages and communicating risks associated with projects; may function as a project manager or team lead for projects.• Collects documents, and manager user, functional, and technical requirements for regulatory information management systems for vaccine biologics business space.• Managed application configuration changes following IT Change Management (ITCM) and GxP Change Control Procedures.• Participate in system validation, release, and post-deployment support activities with Quality, Validation, System Owners, IT Operations, and IT Service Desk.• Provided application support for validation applications.• Interacted with end users on a regular basis to understand their needs and provide guidance and training on technical issues.• Developed processes to ensure high availability of supported application systems.• Troubleshoot technical issues and manage problems through to resolution.• Document common resolutions/solutions and application support processes in the IT Service Management knowledge base.• IT Business Technology Project Lead• Implementation of Schlafender Hase's Text Verification Tool and Lorenz DocuBridge Patch Upgrade

Billingham, Gb

• Ensure that QMS Systems are in a validated state. • Optimize system configurations to maximize performance and ensure availability• Participate in planning and implementation of system changes and upgrades• Perform periodic maintenance and systems review, including security roles, performance, anddata integrity• Maintain close collaboration with Quality departments, including business system owners (design and implement new QMS Systems).• Develop and maintain system documentation• Support internal and third party inspections and audits (FDA, EMA, Clients, etc.)• Troubleshoot and resolve questions/problems with assigned applications• Resolves and/or coordinates the resolution of technical issues with assigned applications• Create documentation for assigned applications and internal processes (SOPs).• Docsign System Administrator.• MasterControl System Administrator.• Empower 3 System Administrator.• TrackWise 10 System Administrator.

Tampa, Florida, Us

• Responsible for administration of MasterControl 11.6 and Sparta Systems TrackWise Digital (Platform, EQMS, Complaints, Audit, DMS and TMS)• Provide end-user training and being a supporting role for all departments and areas • Troubleshoot end-user issues and recommend and implement corrective solutions • Responsible for creating and maintaining user profiles and security roles and the ability to provide audit reports on demand to meet business and regulatory requirements• Responds to internal and external customers to resolve their technology problems• Ensures all Changes and requests are documented and completed with proper documentation for business compliance and/or GxP compliance• Reviews of changes for potential conflicts and tests new software features, functions and releases.• SME - TrackWise Digital and MasterControl. • Create and maintain instructions and documentation for end-user and administrator tasks.• Implementation of Sparta Systems TrackWise Digital EQMS (CAPA, Nonconformance,Incident Reporting, Complaints, Audit, and Deviation), DMS and TMS.• IT Validation - Validation Plans, URS, FRS, Design Specs, IQ, OQ, PQ, Validation Summary Reports.• Completed Salesforce Provided Training: Administration Essentials for Experienced Admins (ADM211)• Completed ISPE Basic Principles of Computerized System Compliance using GAMP 5

Tampa, Florida, Us

• MasterControl System Administration (MasterControl 11.6 QEM, Document and Training Module • Responsible for providing technical support related to software applications and hardware • Provide end-user training and being a supporting role for all departments and areas • Troubleshoot end-user issues and recommend and implement corrective solutions • Responsible for creating and maintaining user profiles and security roles and the ability to provide audit reports on demand to meet business and regulatory requirements• Responds to internal and external customers to resolve their technology problems• Ensures all Changes and requests are documented and completed with proper documentation for business compliance and/or GxP compliance• Reviews of changes for potential conflicts and tests new software features, functions and releases.• SME - TrackWise Digital and MasterControl. • Create and maintain instructions and documentation for end-user and administrator tasks.• Implementation of Sparta Systems TrackWise Digital EQMS (CAPA, Nonconformance,Incident Reporting, Complaints, Audit, and Deviation), DMS and TMS.• IT Validation - Validation Plans, URS, FRS, Design Specs, IQ, OQ, PQ, Validation Summary Reports.

Tampa, Florida, Us

Master Control System Administrator :Responsible for maintaining current modules within MasterControl and identifying the need for new modules based on company needs.Configure and maintain Infocard types, Roles, Vaults, Lifecycles, Routes, and PDF publishing settings for the MasterControl system.Manage user accounts and assign/maintain proper rights and roles to each user/user group in the system.Develop and maintain an overall system configuration matrix, ensuring changes to the system are properly documented.Review and approve Computer System Validation documents such as: Functional Requirement Specifications, Test Summary Reports, Risk Assessments and Pre/Post-Executed Test Scripts.Perform relevant UATs for upgrades to the system.Resolve configuration issues within MasterControl. Work with IT and/or MasterControl support, when necessary, to ensure issue resolution.

Stamford, Connecticut, Us

Resolve all advanced (level 2 or higher) end-user related support for site personnel as escalated by the Central IT Help Desk. Responsible for all back-end IT administration located at the facility. This includes server administration of all the local servers and backup administration. Network infrastructure (switches, routers, network data connections). Work closely with Corporate Information Technology department to identify and address facility related technology requirements. Also work closely with local Management to act as a liaison between corporate information Technology and the Vernon Hills Management. This involves communicating IT projects, direction and systems status to local management to align with business initiatives. Identify current and emerging technologies initiated at the facility, scheduled for deployment across all manufacturing plants. Work closely with the IT Technical teams (Network/Server Managers, other Site Administrators) to collectively define the technical leaders for each project. Serve as a technical leader in some of the projects where required and applicable. Travel to Harman Data Centers and provide hands on support in Downtown Chicago and Elk Grove Village, IL.

Bad Homburg, Hessen, De

Duties include System Administrative support of the Waters Empower Chromatography system. Validation of new computerized systems and HPLC’s. Incident management, coordinating with outside vendors for support of HPLC’s. Application Support of Empower 2 CDS, Chemstation, Dionex, AB Sciex and Chromelon. Updated system administrator SOPs in Documentum and deviations using Track wise. Coordinate testing, and implementation new CR 21 part 11 compliant systems. System Administration of all standalone computerized instruments and Empower 2. Monthly backups of the Empower 2 servers and standalone computer systems, maintain the Empower servers, qualify and validate new computer systems. Receive trouble work tickets via email or by LWOs Troubleshooting of clients and Empower 2 servers and provided support for Melrose Park facilities. Ensure that Empower 2 issues and client issues are resolved in a timely manner using ITIL best practices and coordinating with outside vendors or the IT department staff in resolving the Empower 2 CDS issues. Escalate when necessary to the appropriate vendor or IT department group. Responsible for the creation and management of Empower 2 and numerous application level user accounts. Identified and resolved and escalated related Empower 2 CDS tickets. Served as a technical roll in troubleshooting Empower 2 CDS (Level 2 - 3 support) and standalone computerized instrument issues effecting production. Maintained the Empower 2 CDS Oracle Database and ran SQL queries. Project Management.

Tokyo, Jp

Responsibilities included resolving level 1 ticket. Imaging and deploying computers per Takeda SOP. . Provided level 2 – 3 desktop support to TPNA, TPMX, TPI, TGRD (R&D) and TPC employees.Troubleshot computer equipment,network connectivity, provided software support (TGRD FDA Validated systems), and deployed computers. Company software included MS Office Suites, eCSD, Documentum, ARISG, OPS, Service Desk, Windows NT – Windows 7 Coordinated with other MIS departments to get issues resolved in a timely manner and fallowing up with clients that there issue has been resolved using ITIL best practices. Responsible for providing level 2 - 3support to the Research and Development departments of TGRD. Assisted with projects and supported in regards to new R&D systems (Galaxy, Endnotes X, Global Submit, Arisg, Autocode, ISI Toolbar and RMS).Transferred to the Conway Park Campus to continue in supporting TGRD. Assisted with the restacking of the Records Operation Group in regards to their scanner and Input Acell upgrade This includes the selection and testing of new Fujitsu document scanners. Also, responsible for supporting and managing the ILAB Service in all campuses and the support of the video and Telepresence conferences in the Deerfield Campus. FDA Advisory Meeting Support, managing TGRD, TPNA, and TPI Executive Support use of Altiris to deploy software and GHOST to image machines. Utilize best practices using ITIL 2.0Worked with other IT groups to come up with solutions for departs that I support. Assisted in establishing SOP’s for supporting affiliates outside the U.S. (Canada and Mexico offices). Serve as a liaison and technical advisor between internal customers and functional IT departments during the initial phases of development efforts for various Research and Development departments. Break Fix of Takeda (HP and Lenovo laptops) hardware in the production environment.Software testing, documentation of fixes and installs. Lake Forest R&D Desktop Support Lead.

Us

Responsibilities included resolving level 1 tickets. Imaging and deploying computers per TAP SOP for the IMAC Project. Provided level 2 desktop support to TAP employees. Troubleshot computer equipment, network connectivity, provided software support (TAP FDA Validated systems), and deployed computers. Company software included MS Office Suites, Lotus Notes,eCSD, Documentum, ARISG,OPS, Service Desk, Windows NT – XP Professional. Coordinated with other MIS departments to get issues resolved. Responsible for providing level 2 support to the Research and Development departments of TAP using ITIL 1.0 best practices to ensure that issues are resolved in a timely manner. Assisted with projects in regards to new R&D systems (Eleris and Docubridge). Transferred to the Conway Park Campus to continue in supporting TGRD. Familiar with documentation of IQ/OQ’s of validated Applications. Currentl y assisting with the restacking of the Records Operation Group in regards to their restacking. Which includes the selection and testing of new Fujitsu document scanners

Lake Forest, Il, Us

Responsibilities included level 2 desktop support. Deployment of the new AT&T VPN software on Dell laptops and troubleshooting the new dialer. Resolved level 2 tickets at various Hospira locations throughout Lake County. This included installing new software, resolving hardware and software issues. Transferred to level 1, Pleasant Prairie, WI. , took inbound calls and responded to e-mails from national and international Hospira employees. Provided remote VPN, MS Office Suites and other application support. Reviewed PC Equipment Request Forms for completeness. Remote support of Hospira’s field sales force. Also, included basic trouble shooting Mercury,OPS,E-Docs,Doumentum, ARISG, AES,HES.Trained at Hospira to provide SAP support.