Management Manager

JESSICA SEDA

Telephone: 787-***-**** I E-mail: acs8te@r.postjobfree.com

PROFESSIONAL SUMMARY

Experienced, knowledgeable, and results-focused management professional with 12 years of progressive experience across the Aerospace, Pharmaceutical, Biotechnology, Medical Device and Construction industries. Dynamic collaborator who utilizes creativity, leadership and teamwork to design and execute solutions that create customer value. CORE PROFESSIONAL COMPETENCIES

Configuration/Data Management - Project Management - Contract Management - Change Control - Document Management - Engineering - Program Management - Compliance - Sourcing - Supervision PROFESSIONAL EXPERIENCE

Zimmer Biomet, Ponce, Puerto Rico September 12, 2014 to the present RCM Technologies - Trident Remediation Project

Sr. Change Control Specialist – Consultant/Contractor

Leaded the change control process for the quality systems and supplier qualification divisions; ensured that proposed changes incorporated the necessary evidence to justify modifications and that the implementation activities with the applicable regulatory requirements were identified, reviewed and integrated.

Chaired the Change Control Review Board (CCRB) meetings with key stakeholders (Engineering, Compliance, Quality, Validations and Supplier); presented and discussed modifications for approval and execution activities.

Assisted engineering and acted as the focal point for the preparation of Non-Conformance Events Reports (NCER) and CAPA investigations, preparation/revision of SOP’s, technical writing of change requests and evaluation and approval of change controls. Honeywell Aerospace, Aguadilla, Puerto Rico May 03, 2010 to September 12, 2014 Aero Sourcing & Procurement

Specialist Sr. Commodity – Supplier Contract Negotiations

Leaded competitive contract negotiation, procurement and sourcing activities including Request for Proposal (RFP), Request for Quotation (RFQ), forecast evaluation, market cost analysis, supplier quality performance evaluation, bid pricing analysis, e-auctions, strategy planning and negotiation of contract terms and conditions.

Presided Stakeholder Reviews and obtain buy-in and approval for all negotiation strategies and contract agreements.

Honeywell Aerospace, Aguadilla, Puerto Rico

Engineering and Technology Operations

Configuration/Data Manager Defense and Space Programs

Served as the primary Configuration and Data Manager of defense and NASA (National Aeronautics and Space Administration) program’s such as: B2 Bomber, Viper M160/600, Spirit, CrIS J1 Geospatial, Nuvision, Iridium Next, JPSS, SMAP, International Space Station (ISS) and Constellation Space Suit System (CSSS); facilitated the coordination and administration efforts of contract management activities related to the issuing of data calls, conducting data reviews, CDRL/SDRL preparation/submittal, evaluation of contract Statement of Work (SOW) and review of ITAR/EAR data rights/licensing to ensure compliance with export control regulations.

Directed compliance activities by tracking and monitoring the approval status and release of contract data requirement list items (CDRL's/SDRL’s) engineering change proposals (ECP's), change requests

(ECR's), change orders (ECO's), Engineering Bill of Materials (EBOM) and Notice of Changes (NOC).

Leaded program internal Change Control Board (CCB) meetings to assess modifications and changes for the approval of contract data items (CDRL’s/SDRL’s), engineering drawings and engineering bill of material (E-BOM).

Monitored the delivery and approval of contract data items (CDRL’s/SDRL’s) and provide customer disposition status to program manager and stakeholders. Jessica Seda Resume

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Attended program monthly meetings with the customer and provide status of data item approvals and any pending item’s awaiting disposition.

Served as the focal point for staff, project members and customer pertaining data management issues, status and compliance activities.

Developed and maintained the network share contract data item library/archive for traceability purposes; managed the retrieval of items when requested by engineering.

Created, write and re-write the Data Management Plan to comply with the requirements of the statement of work.

Evaluated Statement of Work (SOW) CDRL/SDRL information and develop the basis of estimate (BOE) for proposal activities.

Facilitated mentoring and training to fellow team members in configuration/data management processes and contractual requirements.

US Army Corp of Engineers, Ponce, Puerto Rico 2008 - 2010 Aerotek Scientific Staffing

Document Control Lead

Assisted engineers in the preparation, recompilation and revision of submittals to comply with project milestones.

Implemented tracking and document archival systems to maintain tests results, document changes, data submittals, equipment inspections and employee trainings.

Evaluated the documentation received from the US Army Corp of Engineers, either administrative or technical documentation in order to prepare responses, submittals and amendments.

Supervised the activities of Project Document Control personnel to ensure that all documentation received was properly evaluated and distributed efficiently in compliance with project agreements established with the army.

Bermudez, Longo & Diaz Masso, Lajas, Puerto Rico 2007-2008 Project Coordinator

Supervised office administration personnel, distribute work assignments and provide training related to office applications and processes.

Managed the recruiting process of staff; conducted candidate screening and interviews.

Worked with corporate finance and payroll departments for the reconciliation of supplier bills, invoices and employee timesheets.

Prepared purchase orders and requisitions for the acquisition of general office supplies and construction materials.

Provided support in the preparation of project certifications by collecting supplier/vendor documentation, evidence of material on site, employee’s payroll information and invoices. Schering Plough Pharmaceuticals, Las Piedras, Puerto Rico 2006-2007 Weil Group Consulting Services

Document Control/Validation Specialist Consultant/Contractor

Acted as liaison between project manager and team of developers located in Southeast Asia and Europe to ensure that all documentation necessary for the qualification of a new manufacturing facility was received on time and that it comply with standards and procedures.

Provided technical writing assistance to team members by creating, writing / or re-writing and translating SOP’s, controlled forms, references, manuals and training materials.

Reviewed and audit validation protocols; ensure process consistency, accuracy and general quality.

Mentored group of documentation coordinators and provide training in good documentation practices

(GDP’s)

Jessica Seda Resume

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Amgen Manufacturing Limited, Juncos, Puerto Rico 2005-2006 Kelly Scientific Temporary Services / Anovis Corp. GMP Specialist / Document Control Consultant/Contractor

Leaded the activities related to the management and implementation of quality documentation systems in accordance with Title 21 CFR Part 820 and ISO 13485 standards.

Coordinated the creation, control and maintenance of data history files, SOP's and master records in the document management system according to current good manufacturing practices (cGMP’s) and ISO standards.

Formatted and revise documents; assisted in the review and approval of documents with engineering and quality departments.

GlaxoSmithKline, Cidra, Puerto Rico 2004-2005

Kelly Scientific Temporary Services

Metrology Validation Specialist

Assisted engineers in the execution of Installation Qualification and Operational Qualification Validation Protocol’s for Incubators, Laboratory Refrigerators and Millipore Water Purification System.

Supported the preparation of validation documentation packages for Quantic/ FDA auditor’s review. Cordis LLC, a Johnson & Johnson Company, San German, Puerto Rico 2003-2004 Kelly Scientific Temporary Services

Engineering Compliance Support Associate

Review and collect data from batch record’s and assisted project team in performing out specification investigations.

Prepared documentation packages for engineering review and support team in the evaluation of data to determine the impact of nonconformance in processes in order to closeout investigations. EDUCATION

Inter-American University of Puerto Rico

Currently pursuing a Master’s of International Business Administration (MIBA), Major: Human Resources Pontifical Catholic University of Puerto Rico

Bachelor’s Degree in Business Administration (BBA) Major: Public Accounting COMPUTER SKILLS

Matrix One/ Product Data Management (PDM) - Teamcenter - Northrop Grumman Livelink SharePoint - Northrop Grumman OASIS - Exostar - Lockheed Martin SharePoint - Boeing Supplier Data Transmittal

(SDT) - DAPTIV - Exelis SharePoint - ENOVIA - Onesource - iMany Contract Management - Dexcenter - Visual Compliance - Ariba - Webplan - Microsoft Word, Excel, Access and PowerPoint - Adobe Professional Trackwise - Documentum - Docwize - Sage Timberline TRAINING

Honeywell Six Sigma Greenbelt

RECONIGTION

2015 Zimmer Biomet Trident Remediation Project Recognition Outstanding Performance supporting remediation activities to comply with FDA commitments 2014 Honeywell Employee Silver Award

Exceptional results in contract negotiations and productivity 2013 Honeywell Employee Bronze Award

CDRL Notice of Change Process Compliance and Quality

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