Paula D.

Duka 3010 KEM RD PENNSBURG, PA 18073 Primary Phone: 267 923 8269 Cell Phone: 215 350 3149 Email: pd1afc4aa@westpost.net EXPERIENCE PPL Generation LLC Contract Allied Resources Allentown, PA 05/17/2010 04/13/2011 Compliance Analyst Establish and execute processes, procedures required by the North American Elect ric Reliability Corporation Critical Infrastructure Protection (NERC CIP) Standa rds (CIP 003 to CIP 009) Cyber Security. Maintain evidence documentation, creat e general compliance communication correspondence to field. Sanofi Aventis Contract E Team Inc. Malvern, PA 04/06/2009 08/19/2009 Batch Writer Support Clinical Packaging Operations Managers establishing Packaging Master Bat ch Records and/or resupply of Packaging Orders for Investigational Product clini cal studies for Phase I, Phase II and Phase III. Quality check Bill of Material s and confirm all supporting documentation i.e. Extended Synopsis, Protocol, Inv estigational Product Packaging Specification, Investigational Product Packaging Order and Clinical Study Batch Validation documentation was approved. Prepare P ackaging Master Batch Records in accordance with all proceeding documents mentio ned above and create instruction page (Poster for use during operations) which i ncluded visual diagrams to reflect the flow of operations required for assembly and collation of active / placebo kit packages. Wyeth Pharmaceuticals Contract Devon Consulting Collegeville, PA 10/16/2007 09/24/2008 Global Product Conformance Document Analyst Documentation collection of Chemistry Manufacturing & Controls documentation for Wyeth Drug Products and Over the Counter Products. Request, receive, review an d quality check documents from Latin America Affiliates. Manage and submit docu mentation to Translation Vendor for documents received in Spanish and/or Portugu ese for translation to English. Electronically scan documents for electronic ac cess within the Wyeth Electronic Document Management System. Train new hired Sp ecialists employed in the Collegeville Data Factory on the Data Collection Proce ss. Teva USA Pharmaceuticals North Wales, PA 11/27/2006 05/30/2007 Document Specialist Documentation Changes to FDA GMP Master Batch Records for Manufacutring and Pack aging of Drug Products for human consumption. AstraZeneca Pharmaceuticals Wilmington, DE 02/04/1995 08/31/2006 Master Batch Record Specialist Provide USBC Change Control support for local Newark Plant site. Maintained chan ge control documents that are cGMP critical and subject to FDA inspection. Proce ssed and coordinated the submission and approval process for Change Control Requ ests. Provided standardization, direction, compliance assurance and implementati on strategies for inclusion in Change Control Requests to ensure efficient chang e implementation at the Newark Production site. Coach key users at USBC and Newa rk sites regarding change control business processes and for using the AstraZene ca s Technical Document Management System (TDMS) the validated, application used to management change control. Co ordinate the development, maintenance and impl

ementation of cGMP compliant Master Batch Records for product manufacture and pa ckage. Monitor MRP production schedule, work closely with Production Planning an d in line with AstraZeneca s Demand Driven Supply process to ensure Master Batch Record revisions are available on line for production. Evaluate and bundle subm itted changes via the Change Control Request and ensure scope of change is prope rly documented and that products and documents tagged as affected fit with the i ntent of the change. Department representative for projects related to Master Ba tch Records. Maintain and update SOPs related to Master Batch Records reflecting current practices. Support execution of TDMS functional test scripts. Internal and External customers supported are: Manufacturing and Packaging Technical Serv ice groups, Site Operations, Production Planning, Information Technology groups, other Quality Assurance groups, Operations Program Management and Chemistry, Ma nufacturing Controls (CMC) Operations Strategy group. Merck Manufacturing Division 04/01/1990 02/04/1995 Senior Secretary West Point, PA

Provided administrative support to lead engineer and ten of his direct reports. Served as co administrator for Pharmaceutical Engineering and Technical Services (PE TS) department s Local Area Network (LAN). Coordinated new hire interviews and handled all paperwork surrounding the prospective candidates visit. Maintain ed department s Standard Operating Procedures and maintained other confidential information, project files, Product and Process Information Summary, Manufacturi ng Process Descriptions in the PE TS library. Responsible for creation and revis ion of various Master Process Descriptions in MMD s TSO system and Installation Qualification/Operation Qualification (IQ/OQ) for PE TS staff. Processed and mai ntained monthly Process Change Request documents/monthly reports. Streamlined th e process for these monthly reports and data exchanges between PE TS (worldwide technical services group and domestic technical services group). Prepared and pr ocessed monthly capital engineering, solvent emissions, absences, and training r eports. Succeeded procuring significant, long awaited capital engineering expens es credit to PE TS budget from MMD, Puerto Rico site. Promoted to higher grade s ecretary level in PE TS. Hamburg, Rubin, Mullin, & Maxwell Lansdale, PA 03/01/1987 04/01/1990 Legal Administrative Assistant Provided support to attorney who handled litigation, estate planning and domesti c relations cases. Prepared legal documents for filing with court clerk within v arious Pennsylvania counties. Notary Public. Calculated and processed monthly client billings. Maintained Accounts Receivable records. Review documents from word processing department to ensure accuracy fo r content and formatting. Maintained numeric and alphabetical client files and a rchiving client files as appropriate. Maintained weekly follow up report highlig hting filing due dates. EDUCATION Eastern University 09/01/1999 05/12/2000 St. Davids, Pennsylvania Bachelor's Degree or Equivalent Major: Business Montgomery County Community College 09/01/1986 06/01/1987 Blue Bell, Pennsylvania Associates Degree

Major: Legal Secreatarial Science Upper Perkiomen HS 09/04/1978 06/12/1981 Pennsburg, Pennsylvania Attained High School Diploma SKILLS AND ABILITIES Adminstrative Assistant Proficient with Microsoft Office Applications: Outlook, Excel, Word, Access, Fro ntPage, AstraZeneca Sales Tools Applications: Sample Allocations, Business Objec ts, Compass/Northstar (electronic hand held sample device and customer database) , Documentum (Technical Document Management System), mySAP (SCMQ), Clinical Supp lies Management System, TRIM Records Management Application, Local Area Network Administrator, Montgomery County Information Systems, Notary Public, GMP and PDM A experience. Notary Public Was a Bonded Notary when employed at lawfirm as a Administrative Assistant. Owner Small Business Established small home business providing: general documentation services, healt h and beauty products (Product Line: Camileon Heels, Arbonne Swiss Skin Care N utrition, Enzacta). Divine Connections through TylersFlower is focusing on Abund ant Life. Looking and feeling great with