Iris Ortiz Email & Phone Number

Fort Worth, Texas, United States

• Conduct compliance review of all quality system document submissions (ECN – Engineering Change Notices and CAR - Change Action Request) to our QMS requirements. Identify any non-compliance issues & effectively communicate to requestors in a clear and concise manner these discrepancies; monitor and trend these occurrences utilizing both Net-Regulus, Excel and other reporting tools. • Facilitate the timely change, approval and release of product documentation and data to include ECN’s, Device Master Record authorization documents, product/model numbers, Product BOM /Router /DIR / Master Record information in SAP, manufacturing processes, and document archiving. • Facilitate the timely change, approval and release of Quality System documents to include SOP’s, Quality Forms, Quality Manual, and Sector SOP’s utilizing the Documentum application. This includes assisting with customer service support on document editing, content structure, QMS impact, and the routing / approval process. • Assist in the creation, maintenance, and implementation of department processes, procedures, and work instructions as required to demonstrate compliance with the Quality System. • Assist in monitoring configuration management process effectiveness including the impact of changes and take the initiative to recommend configuration management process improvements to lead or supervisor. • Work with team members to resolve issues arising from day to day operations • Partner with other functional areas internal and external to the department to facilitate process improvements. • Assist in providing hands on training and consultation to clients on the use of the Documentum and other department tools as required such as (SAP BOM / Router / DIR / Master Record information). • Participate in and lead special projects as assigned

Dallas/Fort Worth Area

Responsible to edit, coordinate review and approval of documentation including Risk Management ReportsManages release and control of updates to instructions, specifications, drawings and other documentsControls distribution of new releases and recall/destruction of obsolete document Expert level skills with MicroSoft Word 2010 (formatting, editing, comparing documents, tracking changes, generate templates). Work with Web collaboration tools (such as SharePoint and Lync) Responsible to tracking and cross references sheets, pivot tables, simple calculations

Lincoln, Nebraska Area

Documentum (Document Control Software) Administrator and Key User. Responsible to maintains and improves the workflow of changes to controlled documents. Document Control System Key User for the site to assure all documentation required to Go Live SAP’s project were update. Interact with different departments to assist in the controlled documentation as per required.

Humacao, Puerto Rico

Documentum (OTC Docs) Administrator and Key User. Responsible for maintaining the document control systems, including user account maintenance and training records. Establish and maintain the system managing all controlled documents generated within the quality system and laboratory testing. In charge to coordinate the review and revision of Procedures, Spec and Forms as per required. Managed the transfer of current effective documents from a manual system into Documentum System. Provides documentation and configuration management support to the entire facility. Responsible for manage, coordinates training and user account set up to new system users. Preparation Room Leader, when FDA Audits was in the Plant, ensure documents delivered to the Audit Room are correct and properly identified, log every document requested by auditor and prepare reports, manage the communication between the Audit Room and Preparation Room.System Site Administrator for applications such as Document Control Software, Batch Records, Validation Numbering, and Master Packaging Orders (electronic and hard copies).User of Consumer Relationship Tracking System, to prepare management reports regarding generated Complaints to the site. Assist compliance team to close complaint’s investigations. Keep inventory file of Consumer Complaint Sample Receipt.Coordinate and / or performs maintenance, and control in a timely manner of regulatory batch specific documents from Technical Operations: Quality Assurance, Manufacturing and Packaging Departments, Engineering and Maintenance Departments.Maintains and/ or performs the archival of Master Batch Records, Master Packaging Orders, Quality Control Records, Validation Documentation, Test Methods, Standard Operating Procedures (SOP’s), Technical Operating Procedures (TOP’s), audit reports and any other GMP documentation related to Good Laboratory and Good Manufacturing Practices. Place Packaging Order and Batch Records in Effectiveness.

Humacao, Puerto Rico

Perform daily administrative duties for directors, managers, and department staff in the Manufacturing, Packaging, Planning, R&D, Packaging Development and Technical Services departments. Manage and administer Standards Operating Procedures (SOP’s) and Master Batch Record processes including: generate, revise, type and edit SOP’s/MBR’s, keep tracking of the system, assign SOP’s deviations number and expiration date, copy and distribute procedures, change procedures to PDF format, and maintain electronic system updated. Generate manufacturing and packaging Batch Records from Master Worksheet for the production and packaging areas according to schedule, and packaging orders from master records according to planning requirement. Perform data entry for CAP System training records. Maintain control of Validation/Qualification Protocols and Amendments documentation according to the established procedure. Sr. Administrative Assistant – Technical Services/QA 1995 - 2000Support and assist during the development and control of the budget for different Cost Centers. In charge of all documents that FDA requests in audit visit. Record and file documents that FDA requested and generated in audit visit. Assign number, records and file all Change Request document. Administrate Master Batch Worksheet’s system. Generate exceptions to Master Batch Worksheets, assigns number and expiration date, transfer to production clerical personnel and retrieve obsolete records. Prepare copies of Batch Worksheets to be executed in the manufacturing area in its respective color. Generate, revise, type, and edit SOP’s and maintain logbooks of SOP’s, Plant Test and Amendments to Plant Test, Experimental Lots, Failures and Change Controls analyzed or reviewed by TSD Specialists

Bachelor, Office Administration, Cum Laude

•Graduated with Honors in Office Administration.

High School, General Studies

Education record

Master'S Degree, Education In Office Administration