Support the overall growth of the company by implementing Quality Master Data Systems, presenting New Hire Orientation, and supporting Process and Software Improvements.Requirements gathering from technical teams wanting to put items in Oracle.Volume building of master item data (1000's) for US and global divisions into Oracle, MS Office systems and servers.Use diverse technology (Oracle, MS Office, Adobe Acrobat, and servers), quality and pharmaceutical experience to understand the functionality to develop catalog items.Met urgent request deadlines by improving a standardized paradigm, reducing tracking time by 75% (avg 1000 hrs annually). Revised labeling master data items (1000) for a massive Serialization project.Resolve regulatory labeling format issues and support work processes.Use key systems and metrics to make actionable decisions.Assist in the compliant case processing of AE, non-AE, and information reports.Liaise with PV staff for case processing clarification.Assisted in revision/creation of case processing procedural documents and presentation revision.Interact with the offshore team to review developed items and resolve issues.Lead departmental initiativesRepresent QA in project meetings.Provide audit support.Participate in New Product launch teams to independently provide regulatory labeling format assistance to obtain rapid and timely approval of new products.Present New Hire Orientation on GMP and Pharmacovigilance training and administer tests.Maintain collaborative relationships with US and global functional groups.Support upper management, i.e. orient New Hires, updating/authoring SOP's on item code issuance and suppliers, Manufacturing/Packaging batch issuance/checking , change control, create/maintain model document templatesLead cross-functional projects: make volume R&D/Lab technical documents (100's-1000's) effective, archive electronically and physically.

 Managed the company’s largest account, using English to interact with the customers and Spanish with colleagues to execute volume large orders. Found $1000's outstanding unpaid by clients. Introduced and configured a voice mail answering system to save time for the clients and operations Utilized PowerHouse (MRP) to design thousands of labels for raw materials while managing 100's of spreadsheets of customer orders, containing 100's of transactions and formatting Microsoft Word documents  Performed batch record review and volume entry of batch reporting data (100's) (PowerHouse (Oracle-based) and applicable Product Databases). Identified and notified management of operator documentation error trends noted during batch record review. Provided back-up support to management

 Maintained all ISO and FDA standard operating procedures, work instructions and forms.  Created a consolidated library, paper and electronic, of medical-device-related documents, i.e. Devise History Records, resulting in timely access and reduced tracking time. Maintained site-wide document archival room. Control of validation records, design control documents, Device History (DHR) and Quality System Records. Modified and updated MS Access and Excel databases, conducted queries, analyzed data and created reports or forms (i.e., mailing lists, customer records, etc.) to improve inventory management and reporting accuracy.  Processed volumes of international background checks of vendors, using Adobe Acrobat. Assisted in the configuration and installation of proprietary software on laptops. Improved the set-up instructions to streamline the process, which improved efficiency by 50%.

 Supporting global clinical trials, managed registrations for new users and site administration (50-100 day), encoding details into the company portal and data storage site, Medidata Rave; authorized requests, provided requester feedback, reported activities, and migrated data from Word, Excel files, Siebel to Rave.  Promoted to pioneer quality checks for digital submissions (100 daily) to pharmaceutical clients and clinical trial patient data to clinical research organizations for submission to the FDA.

 Assumed responsibility in managing and processing a number of like insulin product cases consecutively, thereby boosting productivity by 200%. Trained colleagues on Case processing. Created work instructions. Recovered volume insulin product case information (medical inquiries, complaints, non-adverse and adverse-event) from a Siebel mailbox to transfer, process, and reconcile into a global SAP product technical compliance (PTC) database. Preparing timely pharmacovigilance reports for products, i.e. Individual Case Summary Reports (ICSRs). Determined follow-up requirements for AE, non-adverse and inquiry reports and ensured its collection by generating corresponding letters. Evaluated current and proposed processes/procedures to identify quality and efficiency improvements Ensured that the tracking of inflow of cases and triage of initial and follow-up information received were processed in a timely manner, consistent with SOPs. Ensured compliance with FDA regulations regarding collection, verification, and maintenance of records concerning technical complaints and adverse drug reports and correct problem code and failure-code classifications were assigned for trending for compliant data analysis. Liaised with other functional areas such as Safety Physicians, Customer Service, Training, and Quality, as needed, to clarify proper details for case processing.

 Retrieved and observed a large volume of data containing new descriptive pharmaceutical document names (100+ daily) in databases, worksheets, PDF, and Word documents Assisted levels of management in manager’s absence, after business hours, to track electronic and physical files, using MS Access and Excel, promptly and professionally.

• Served as the primary point of contact for a diverse and large client base in the application process (25 daily) to purchase a dialysis product, resulting in $100000s in revenue. • Researched, verified, reviewed, processed, filed, tracked and logged volumes (100+ daily) of client applications.• Searched, entered, and managed volume data in CARS (Citrix) purchasing contract system), MS Excel and Word files.

 Leveraged technical mastery of Ariba and SAP to evaluate internal purchase and maintenance requisitions (25-50 daily)• Having a Grant of Authority of up to $50k and received from all Divisions of Merck for products and services, used Ariba and SAP to review internal purchase and maintenance requisitions, within set time frames and enabling the end-to-end process, as well as meet the needs of the business. • Monitored the Ariba server queue to process volume purchase and maintenance requisitions.• Ensured requisitions were complete and accurate based on quality requisition guidelines and all necessary approvals were provided prior to issuing the final Purchase Order. • Interfaced with all levels of management within Merck, as well as external suppliers, to obtain clarification and supporting documentation when necessary.

• Supported the Compliance Submission Initiative team goal, paper and electronic data management system, and quality control of regulatory global submissions and Common Technical Documents.• Sought ways to identify, apply, create and share SOPS and business processes, performing beyond my role. Adhered to GMPs.• Identified trends for process improvement and metrics collection, using Excel, PRISM and CARA, reducing tracking time by 75%. • Executed user acceptance testing, performing beyond my function. Assisted peers.• Trained users on IRIS for content building and management and running reports of global drug filings, effective beyond my function. Assisted with maintenance.• Partnered with Regulatory managers and IT support to assist in review of system changes, ensure data integrity and perform data uploads in IRIS, optimizing system performance and metrics by 25%.• Provided training materials, which streamlined process of using a UNIX-based interface in IRIS, resulting in > 80 percent of effective usage.• Participated in product launch meetings, established milestones for my part, tracked status, submitted status reports, and resolved issues. • Used Plateau, a learning management system, and trained peers on usage, effective beyond my role.• Designed and managed MS Access projects, effective beyond my function: a prototype tracking relational database consultant request tracking system, SQL query reports, to streamline the request process and support data analysis.• Exposed to Trackwise to build and maintain project-related fields, files and activities. • Processed PDF submissions in PRISM and CARA, to import and track. Ensured RA and electronic compliance for health agency filings. Trained peers.• Worked with Global Dossier and Document Management and Informatics departments to fix data issues. Translated Italian FHA correspondence for a site in Latina, Italy, which assisted management in decision-making for drug product approval.

• Supported a manager, four clinical research associates, the Hepatology and HIV groups, at least 50 departmental field clinical research associates, and clinical trial coordinators in processing medical data for various studies and protocols and with MS Office applications. Practiced Good Clinical Practices.• Performed quality control on Clinical Trial Applications and data; processed investigational data.

• Supported five product principals and the Pharmaceutical and Animal Health groups to assist in a project to convert their paper process to electronic to route, manage and track Regulatory packages on product change proposals and requests for global submission and FDA approval.• Performed quality assurance on, created, processed and finalized Regulatory Authorization Notifications (RANs), Product Change Proposals (PCPs) review and Product Change Request (PCRs) reviews.• Used an MS Access product database to initiate, revise, review, approve or withdraw, issue, track and distribute RANs, PCRs, and PCPs in accordance with organizational procedures. • Trained peers on MS Access usage and business process, effective beyond my role. • Routed RANs, PCRs and PCPs to product change management reviewers, principal reviewers and site reviewers worldwide, using hyperlinks to PDF files and links within same to legacy documents, for review and approval.• Evaluated, tracked, and organized the retrieval and creation of hyperlinked PDF files of regulatory packages with relevant legacy and non-legacy documents for U.S. and European submissions. • Used MS Excel to generate and track metrics and Regulatory product and management information.• Indexed and archived submission components using Documentum. • Maintained documentation systems to comply with manufacturing practices, regulations, and corporate policies.• Tasked to improve process efficiency, performing beyond my function; Surveyed users on and off-site to gather requirements and documentation, which were used to contribute to devise SOPs.• Provided back-up support to the departments’ coordinators in their absence. • Coordinated with individuals of various levels and groups within Pharmaceutical Sciences to ensure effective document management.