SRC Coordinator at Wyeth Pharmaceuticals
Reading, Pennsylvania Area
SRC Coordinator at Wyeth Pharmaceuticals
Reading, Pennsylvania Area
5/2008-SRC Coordinator- Consultant
Vaccines Wyeth Biotech TO&PS (Technical Operations & Product Supply)
Wyeth BES-(Biotech External Supply) 13V Drug Product
Prevnar 13-valent pneumococcal conjugate vaccine (13v PnC)
Update and edit IND=Investigational New Drug and NDA= New Drug Application submissions so that they meet Submission Ready Component Standards set by the FDA=(Federal Drug Administration).http://www.fda.gov/cber/vaccine/licvacc.htm
Use the WSST Wyeth Submission Style Template when updating documents for quality review in MS Word format.
Perform quality reviews on large scale PDF documents. Work on eCTD=Electronic Common Technical Documents in EDMS=(Electronic Data Management System AKA Documentum) and the internal eSS=Electronic Submission system which is used to assemble and review electronic Common Technical Document (eCTD) submissions as well as other electronic submissions such as eNDA and eIND. Navigate and check out files and create different Renditions of documents in EDMS. Went through multiple CBT and extensive classroom training to gain access to systems. Use Acrobat 7.0 with Compose and ISI Toolbox plug ins. Work in Dossier Development eroom by emc2-Documentum eroom Content Management product.SRC 101 & 201 Training in Pearl River, NY and Compliance & Quality Training FDA (21 CFR Electronic Records & Signatures) (210 & 211 cGMP in Manufacturing,Processing, Packing, or Holding of Drugs and finished Pharmaceuticals) Andover, Mass.
Check out my website www.thirdfloorsolutions.com www.tomcipriano.com and www.tomstechnoportal.com
(Pharmaceuticals industry)
May 2008 — Present (4 months)
(Public Company; 10,001 or more employees; WYE; Pharmaceuticals industry)
December 2007 — March 2008 (4 months)
Shire Pharmaceuticals thru Consulting Co., Wayne, PA
Founded in 1986, we are a global specialty pharmaceutical company with revenues for the full year 2007 of US$2,436 million. Shire currently focuses on the following business units - attention deficit and hyperactivity disorder (ADHD), gastrointestinal (GI), renal diseases and Genetic disorders.
Currently handling all PR/PO's in SAP SRM application. Working with Human Resources, Procurement & Accounts payable to revamp and streamline the payment process. Created and tracked numerous Ad hoc reports in SAP SRM and MySAP/R3. Also using Recruitment Management Application called Projectix First Advantage to enter and modify Job Requisitions thru the hiring process. Created over 1 million dollars worth of Shopping carts in a 2 month time frame to get a backlog of vendors paid which were over 60/90 days delinquent. Department is going through restructuring toward a Shared Services business model.
(Public Company; 10,001 or more employees; WYE; Pharmaceuticals industry)
November 2007 — December 2007 (2 months)
(Public Company; Furniture industry)
August 2007 — November 2007 (4 months)
Windows desktop operating systems, active directory, Lotus Notes, Lotus Quickplace, Lotus SameTime, OS/400/WNT administration, JDE World, printing systems, desktop and laptop hardware, LAN/WAN, Microsoft Office applications, anti-virus, handheld devices (Blackberry), Checkpoint VPN, TCP/IP networking, dialup/broadband, DHCP, wireless technologies, Postini (anti-spam), Email systems, GWI ticket tracking software, account resets, desktop systems reloads, telecommunications and SMS (or any remote support desktop tool).
(Public Company; 10,001 or more employees; Biotechnology industry)
April 2007 — July 2007 (4 months)
SAP HRIS PA20,PA30 & PA40.
(Computer & Network Security industry)
February 2006 — March 2007 (1 year 2 months)
Worked with CA Identity Manager.
(Provisioning,Strong Synch,Rule-based Role based Access Control,Constraints)
http://www.thirdfloorsolutions.com/tomsresume.asp
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
November 2005 — January 2006 (3 months)
See http://www.thirdfloorsolutions.com/tomsresume.asp to find out more info.
(Public Company; 10,001 or more employees; SAP; Computer Software industry)
November 2004 — November 2005 (1 year 1 month)
Handle and distribute EULA's Marketing Agreements, Test and Demo Licenses, SDK, NDA's, Partner Agreements, Maintenance Agreements, and Rider 1 Contracts. Work with EBP SAP's E-Procurement System and ISP which is SAP's R-3 application(R=Real Time, 3=3 Tier). Distribute Marketing Materials and supplies for Partners, Customers, and Team Members throughout the US. Schedule and conduct Partner Webex's and Goto Meeting's. Update Partner Portal website.
Human Resource Management 1998 — 2000
A.S., Criminal Justice, 1994 — 1996
ACT 120, 1994 — 1994