Systems Administrator Customer Service

SUMMARY OF QUALIFICATIONS:

Highly successful life sciences professional with a focus on computer system application configuration and management, business support, training, document management, document review and audit/inspection support. Consistently displays excellent troubleshooting and problem-solving skills as well as good communication and interpersonal skills, with the ability to work well independently and with cross-functional teams. Proven record of performance that frequently exceeds expectations and is supported by an ability to take on new tasks, learn them quickly, exercise independent judgment and execute tasks with minimal to no supervision, while maintaining a high level of productivity and quality and providing excellent customer service/support.

COMPUTER SKILLS:

ComplianceWire, HP ALM, JIRA, Microsoft Excel, Microsoft Word, Power Point, Salesforce, ServiceNow, SharePoint, Trackwise, Veeva Vault (QualityDocs, QMS, Training, SSU & eTMF)

PROFESSIONAL EXPERIENCE:

Civica Rx, Lehi, UT

Veeva Systems Administrator, Quality (August 2023 – Present (Remote))

−Serve as System Administrator of the Veeva Vault Quality Suite Vault (QualityDocs, QMS, Training), responsible for the following: managing user access and permissions; creating, modifying and inactivating user accounts; assigning roles and additional permissions; providing training and support to users as needed; investigating and resolving technical issues as well as user issues and Incidents; proactively identifying and tracking opportunities for system enhancement and optimization to drive effectiveness/efficiency; configuring the system by setting up customized document types, metadata, lifecycles, workflows, and security settings to meet business needs; authoring/initiating change controls for configuration changes; authoring/updating Veeva Quality Suite related business documents; supporting Validation Team by creating test scenarios and authoring User Acceptance Testing (UAT) protocol test scripts; managing Quality Suite Sandbox, Test, Production, Pre-Release and Training Sandbox environments; training System Administrators and Vault Owners; creating/sharing custom reports and saved views that meet the needs of applicable system users

−Collaborate with Veeva Managed Services and Veeva Support Team, as needed, to resolve system issues

NNIT Inc., Princeton, NJ

Senior Consultant, Life Sciences Quality Assurance Delivery

Quality Systems Specialist, Quality Policies & Systems-Foster City (October 2021 – July 2023, Gilead Sciences Project, Contract Position for Foster City, CA (Remote))

−Provided QA oversight for GxP Quality Management and computer systems (Veeva Vault QMS, Trackwise, ComplianceWire) by conducting the review and approval of documents and processes

−Attended cross-functional meetings to support the operation of computerized systems

−Participated in validation protocol review and approval of computerized systems in HP ALM (Application Lifecycle Management)

Configuration Specialist/Validation Support, Vault Quality Professional Services (October 2021 – April 2022, Apellis Pharmaceuticals Project, Subcontract Position for Waltham, MA (Remote))

−Served as Configuration Specialist for Veeva Vault QualityDocs and QMS modules, responsible for the following: participating on configuration review meetings, performing targeted configuration updates to enable new configurations

−Served as Validation Lead for Veeva Vault QualityDocs and QMS modules, responsible for the following management activities for the Performance Qualification/User Acceptance Testing validation phase of the project: authoring Vault Validation Plan, Test Plan, Test Scripts, Requirements Traceability Matrix and Validation Summary Report documentation; providing Vault subject matter expertise and testing support during customer-led testing execution and sign off

Patel Consultants Corporation / Theradex Oncology, Princeton, NJ

Veeva Support Specialist Consultant, Information Systems (April 2021 – October 2021, Contract Position)

−Served as Vault Owner/System Administrator for Veeva Vault SSU (Study Startup) and eTMF (electronic Trial Master File) modules, responsible for assisting in site user issue resolution and authoring/updating Veeva related SOPs and training

−Provided technical support for Veeva Remediation Project

TSR Consulting / Bristol Myers Squibb, Lawrence Township, NJ

BMS System Administrator, Clinical Trials Operations & Strategy (February 2020 – April 2021, Contract Position)

−Provided system administration support to internal and external Salesforce (FastTrack) users associated with Investigator Initiated Trials / Investigator Sponsored Studies

−Supported User Acceptance Testing of system enhancements and upgrades in FastTrack

−Worked with business to identify system pain points, gather and document associated requirements and initiate FastTrack Support tickets for prioritization and resolution to support business needs

−Updated/reviewed training materials related to changes affecting FastTrack and the MyTrials to Shared Investigator Platform (SIP) migration project

PATH, Washington, DC

Quality Systems Administrator, Quality Assurance (October 2018 – December 2019)

−Served as Vault Owner/Quality Systems Administrator for Veeva Vault QualityDocs, QMS and eTMF modules, responsible for the following: assisting in site user issue resolution and closing out Veeva related tickets in JIRA; authoring/updating Veeva related SOPs; training Administrators and new site users, as needed; initiating change controls for needed configuration changes or changes tied to Veeva new releases for auto-on and configurable features; authoring and executing test scripts; managing Quality & Clinical Sandbox Test & Production environments; managing document templates; creating/sharing custom reports and saved views that meet the needs of System Owners and applicable site users; suggesting, tracking, and making configuration changes to the Vaults

−Worked with business to identify system pain points and gather and document associated requirements to develop, configure, test and implement solutions to optimize processes and support business needs

Advaxis, Princeton, NJ

Associate Manager/Quality Systems Administrator, Quality Assurance (July 2017 – October 2018)

−Served as Business Administrator of the Veeva Vault QualityDocs Electronic Document Management System, responsible for the following: assisting in site user issue resolution; authoring/updating Veeva QualityDocs related SOPs; training new QualityDocs site users; authoring/initiating change controls for needed configuration changes or changes tied to Veeva new releases for auto-on and configurable features; managing QualityDocs Sandbox, Test & Production environments; managing document templates; creating/sharing custom reports and saved views that meet the needs of Document Control and applicable site users; suggesting, tracking, and making configuration changes to the system; assisting Information Technology Team in close-out of Veeva QualityDocs related tickets in ServiceNow; executing test scripts for high risk configuration changes; assisting Validation Team in creation of Performance Qualification protocol test script steps

−Worked with business to identify system pain points and gather and document associated requirements to develop, configure, test and implement solutions to optimize processes and support business needs

−Worked with Form authors on the design of fillable forms using Microsoft Word Developer Tools

−Worked with Veeva Managed Services and Veeva Support Team, as needed, to resolve system issues

−Managed and maintained electronic and hard-copy controlled documents

−Reviewed external production batch records and associated data for product release

Maven Talent / Advaxis, Princeton, NJ

Quality Systems Associate, Quality Assurance (February 2017 – July 2017, Contract Position)

−Assisted Project Lead with the implementation of Veeva QualityDocs

−Mapped 700+ documents for migration into Veeva QualityDocs

Real Staffing / Covance Clinical Development Services, Princeton, NJ

EDC Validation Coordinator, Global EDC Solutions Group (January 2016 – December 2016, Contract Position)

−Lead validation projects as assigned and served as a validation team member on multiple assignments as designated by management, with support from senior team members as needed

−Authored, reviewed, approved and assembled eTMF ready documentation packages for Validation Plans, Test Scripts and Testing Results, Traceability Matrices, and Validation Reports

−Executed test cases in Medidata Rave or InForm Electronic Data Capture (EDC) systems

−Entered errors into issue tracking logs, updated test scripts, coordinated retests, documented resolutions, and maintained validation testing documentation and files

−Reviewed User Acceptance Testing documentation and electronic Case Report Form (eCRF) & Edit Check specifications for validation projects

Bio-Pharm Inc., Levittown, PA

Technical Logistics Specialist, Quality Assurance (September 2015 – January 2016)

−Served as site Administrator of the MasterControl Electronic Document Management System

−Formatted Raw Material specification documents for transfer into MasterControl

Schneider Electric/Invensys Operations Management, Andover, MA

Compliance Consultant, Compliance Consulting Group (July 2015 – September 2015, AMPAC Project, Contract Position in Houston, TX)

−Created or revised the following validation documents for the Foxboro I/A Distributed Control System Windows XP to Windows 7 upgrade: Validation Master Plan (VMP), Operating Procedures, Project Application Specifications (PAS) and Installation Qualification (IQ) and Operational Qualification (OQ) Testing Documents

Antares Pharma, Ewing, NJ

Senior QA/QS Documentation Specialist, Quality Assurance (September 2014 – July 2015)

−Performed review of Quality and Document Management system documents

−Coordinated the review and approval of all Antares documents including Commercial and Clinical labels, Product Information Inserts and Instructions For Use

−Prepared Quality Systems related metrics for use in Management Review meetings

Hemispherx Biopharma, New Brunswick, NJ

Quality Specialist II, Quality Assurance (February 2014 – September 2014, Contract Position)

−Performed review of Manufacturing Batch Records and Quality Control documentation

−Provided QA oversight in the packaging and shipping of product to Clinical sites and reviewed shipment documentation

−Generated labels for Manufacturing Group and Clinical studies

−Reconciled labels and processed label requests

−Conducted new employee training

−Coordinated the review and approval of site documents

−Managed and tracked training records using Train Track

−Tracked document metrics

EDUCATION:

Bachelor of Arts in Biochemistry

Vassar College, Poughkeepsie, NY

May 2001

CERTIFICATIONS:

−Veeva Vault Platform Associate Administrator (Expiration Date: December 2024)

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