Annette W. Faust 4092 Freemansburg Ave.

Easton, PA 18045 Home Phone: (610) 253-9926 Cell Phone: (610) 295-9477 E-Mail: af136cd84@westpost.net EMPLOYMENT November 2008 - August 2010 Legacy Schering-Plough (Merck) Summit, NJ Scientist 1 - Toxicology Data Management Responsibilities included all aspects of Data Assurance conducted within the pre clinical Drug Safety Department. As one of the Data Management Archive Coordina tors, supported the archival process and generated reports to notify staff of ar chival due dates. Reviewed notebooks prior to archival submission. As Applicatio ns Administrator overseeing and maintaining computer generated protocols, data, and reports for all studies whereby data is captured via the In-Life Data Collec tion Systems. Worked closely with Report Writing and Study Directors as a member of the Report Generation team to generate final report tables. As a member of the QC/DA resource pool, provided support to other departments when needed for v arious types of data review, training provided by requesting department as neede d. Provide QC for the General and Reproductive Toxicology group and the Genetic Toxicology Group. Provided archiving of data for the Genetic Toxicology group. A ssisted in drafting Standard Operating Procedures and Laboratory Procedures. Mem ber of First Aid team, first responder training required. May 2005 - November 2008 Schering-Plough Research Institute, Lafayette, NJ Associate Scientist, Toxicology Data Management Responsibilities included the Data Assurance of various components for the aspec ts of studies conducted within the General and Reproductive Toxicology areas of the preclinical Drug Safety Department. This includes Data Assurance of tables and text for final reports as well as CTD tables included in regulatory submissi ons. A significant area of responsibility was the data assurance of fully integ rated final reports from Contract Research Organizations for all Toxicology area s as well as Safety Pharmacology. Special requests for Data Assurance also occu rred on a routine basis. Support for the archival process as one of the Data Ma nagement Archive Coordinators was a portion of the core job responsibilities. A ll of these roles were conducted in a highly regulated environment according to Good Laboratory Practices (GLPs). Member of First Aid team, first responder trai ning required. 1999-2005 Huntingdon life Sciences East Millstone, NJ Supervisor Archives S.O.P. Coordinator As Supervisor and GLP Archivist, responsible for secure storage of raw data, rep orts, specimens, samples and other GLP study materials. Manage inflow and remova l of archival materials in accordance with company SOP's and GLP regulations. S upervise Archives staff, and allocate resources to ensure cost-effective, effici ent operations. Serve as primary interface with clients in establishing disposit ion of retained study materials, including shipment and/or destruction of raw da ta, reports, specimens and samples in accordance with client instructions and cu rrent DOT, FAA requirements. Manage SOP coordination and document management fun ctions in accordance with relevant company SOP's. Maintain computerized index of document inventory and status. Responsible for the security and integrity of hi storical SOP files. Interact with technical staff and management to ensure that new and updated SOP's are expediently distributed, and that outdated SOP's are p romptly removed from departmental SOP manuals and discarded. Responsible for ove rsight of the Training Records Database including addition and modification of u ser accounts as requested by departmental supervisory staff. Update status of SO Ps in database as necessary to reflect new training requirements. Review database reports on a monthly basis to alert supervisory st aff of overdue learning point assessments and training records endorsements. Pro vide training on an as needed basis.

1990-1999 Huntingdon Life Sciences East Millstone, NJ Pre Clinical Research Associate Worked with toxicologists to monitor ongoing studies. Served as a liaison betwe en laboratory personnel, Toxicologist/Study Director and sponsor, as needed. Re viewed the literature on experimental compounds and new technical procedures via the Internet and various other sources. Collated data from in-house and subcont racted studies. Prepared protocol amendments and study related correspondence. P repared status reports and completed interim and final reports for Study Directo r and Sponsors. Performed statistical analysis as necessary. Responded to Quality Assurance, Sponsor, and Regulatory Agency Audits. Archived reports and specimens. Prepared Sponsor requ ired data packages for IND submission. Entered on-line protocols for data collection, performed transfer of Xybion data and network files, assisted with user testing, program validation and decommiss ioning. Required knowledge of DOS, Word Perfect, Xywrite, Word, Excel, Lotus, Wi ndows, Artemis and VAX data entry; knowledge of company S.O.P.'s, EPA, FDA, OECD , and JMAFF Regulations, GLP guidelines, the animal welfare act and other regula tions and/or guidelines as specified per protocol. 1987-1990 Pharmaco LSR (currently Huntingdon Life Sciences) Technician-in-Charge Conducted preclinical toxicology studies. Performed in-life procedures, includi ng test article preparation nd administration (IM, IP, IV, subcutaneous, dermal and intubation), clinical evaluations and collection of blood and urinalysis sam ples. Provided assistance with user testing and validation of on-line data coll ection packages. Trained personnel in data collection and in-life procedures. Provided direct supervision of a team of three to five technicians. Was respons ible for performing and/or overseeing five to ten ongoing studies. Assured compl iance with company S.O.P.'s, protocols, G.LP.'s and federal and state testing an d animal welfare regulations. 1984-1987 Ultimate Distribution, Inc. Edison, NJ Sr. Accounts Clerk Performed general maintenance of MDS Series 21 Computer including trouble shooti ng problems with system, repairs of printer, backing up system, creating data en try screens, report layouts, organization of report information and computer dat a files, numerical data entry and verification, transmission and receiving data from main branch, scheduling inbound freight, confirming appointments, answering/screening incoming calls. EDUCATION: Bound Brook high School Graduated 1981 Academy of Business Careers Certificate in Computer programming and Operations (BASIC, COBOL, and RPG II) Cook College AALAS ALA T Certificate Northampton Community College A+ Computer Hardware and Software Pharmacy Technician I Medical Terminology College Keyboarding