SUMMARY:

• To obtain a position where I can leverage my technical, quality assurance, training skills and experience to positively impact the company’s bottom line
• Extensive experience in document control and familiar with numerous Document Management Systems such as Documentum, SharePoint, and Visual SourceSafe
• Hands on experience in Microsoft Office products, Regulatory Information Systems, and Electronic Publishing Systems
• Expertise in translations and associated forms from DocSpace (Documentum) to Veeva Tru - Vault system and migration of Confidential . to Confidential - Direct copy of entire lifecycle piece by piece between Documentum / First Docs repositories
• On-boarding new employees and leading training seminars
• Network administration

TECHNICAL SKILLS:

• Adobe Acrobat O.R.S. Viewpoint AIX 4.3.3
• Clear Quest SAS Viewer MAC 9x, 10x
• Cornerstone LMS Veeva Tru-Vault V.13 Novell 4, 5, 6
• Core Dossier Hardware: SCO 5.05
• Documentum Cisco ASA Windows 7
• DFI S-Cubed Cisco Layer 3 switches Windows 9x
• First Docs Dell, workstations/Servers Windows NT 4.0
• ISI toolbox IBM Servers Windows 2000
• Master Control Macintosh Hardware Windows XP
• Microsoft Office Power Vault DLT

PROFESSIONAL EXPERIENCE:

Confidential

Program Coordinator

Responsibilities:

• In charge of all In-facility testing packet scheduling for Certified Nursing Assistant testing by Nurse Aide Evaluators
• Responsibilities include tracking of all testing packets across multiple states as well as resolution and solution to all scheduling challenges
• Additional responsibilities, resolving NAE questions and needs as well as assisting with onboarding NAE’s and investigation and resolution of any needed queries

Confidential

Document Specialist Contractor

Responsibilities:

• Corporate Procurement project setup work utilizing Sales Force, Veeva Tru Vault, and Sharepoint for deployment of electronic marketplace
• Migration as well as needed manipulation of data ( Confidential ) specifically Category cards within Confidential system with references to regulated documents in Tru-Vault System

Confidential

Document Specialist Contractor

Responsibilities:

• Responsible for migration of 14 Multi-language Corporate SOP’s (Chinese, Japanese, Korean, Hungarian, Russian, etc.) as well as linkes to Translations and associated forms from DocSpace (Documentum) to Veeva Tru-Vault system
• Responsible for mapping and entry of all needed metadata and associated forms and worked in concert with management for any needed changes to metadata and or referenced fields in Tru-Vault system
• Manipulation of files to comply with migration process for easy navigation and accountability in new system with full auditing and check of data integrity
• Ran reports and performed quality assurance for reporting manager

Confidential

Quality Assurance Analyst

Responsibilities:

• Responsible for acceptance/rejection of all company IXRS/IVR system sub builds of software utilizing Clear Quest, company templates, and SOPs and working instructions
• Ownership of entire Curriculum Vitae process within Master Control ™ as well as S.O.P. (Tracking and L.M.S. implementation) for entire Clinical Division
• Confidential Learning Portal (ALP’s) L.M.S. administration and content placement and review
• Ownership of official archive process of all retired systems

Confidential

Clinical Project Assistant

Responsibilities:

• Trial Master File audit and corrections for Pfizer
• Accounted for receipt of the TMF as provided and reported inventory
• Matched and audited multiple pieces of TMF’s for accountability

Confidential

Document Specialist

Responsibilities:

• Lifecycle audit and Migration of Confidential . to Confidential - Direct copy of entire lifecycle piece by piece between Documentum / First Docs repositories
• Administration of SharePoint instances for business units

Confidential

Product Engineer

Responsibilities:

• Worldwide installation and validation of Confidential products for Pharmaceutical industry
• Responsible for Confidential . of all products and for adjustments to the process as well as communication to cross functional teams (writers, developers, managers)

Confidential

IT Specialist

Responsibilities:

• Network administrator of separate production and development domains
• Software and technical liaison for specific applications and processes
• Supported IVR, Clinical and Regulatory functional areas as well as all other corporate functions
• Developed and maintained all departmental documentation

Confidential

Electronic Publishing Senior Associate

Responsibilities:

• Managed all portions of Confidential hybrid submission, largest ever done by the company
• Compiled and produced Confidential sections for eight electronic submissions
• Represented the company at numerous sponsor sites for Confidential production

Confidential

Systems Administrator

Responsibilities:

• Built and administered Windows 2000 network
• Administered and maintained multiple systems including, Win NT4.0 servers, AIX 4.3.3, SCO 5.0.5, MAC OS, and various DiComm systems in accordance with all applicable Hippa regulations

Confidential

Radiology services Coder and Biller

Responsibilities:

• Responsible for all outgoing billing for Confidential County Hospital Confidential interpretation charges
• Billing for other locations ad hoc
• Ad hoc Accounts receivable work