Document Control Customer Service

Nancy J. Urrego

www.linkedin.com/in/nancy-urrego-1bb79429

609-***-**** ***********@*****.***

SUMMARY

Responsible for the prompt handling of documentation via the Agile PLM System change orders. System Administrator responsible for the validation, daily maintenance and performance of an FDA compliant electronic document control system. Lead a team of six (6) employees that launched and routed approximately 30 documents daily (any from 1 to 40 pages long). Additional experience as a Senior Research Technician in the Research and Development area. Strong technical knowledge, leadership, organizational and managerial skills. Excellent interpersonal skills and highly reliable. Valued team player, who sets high standards, takes initiative and provides outstanding technical assistance and customer service.

PROFESSIONAL EXPERIENCE

Medtronic TYRX, Monmouth Junction, NJ 2013 – 2019

Associate Quality Systems Specialist

Responsible for the prompt handling of documentation in the Agile System via Change Orders. Ensure the routing of high priority change orders within two (2) hours of submission. Managed and maintain training documentation for TYRX.

Manage all Quality system related controlled document and files, maintaining traceability, tracking during approval, notification of approval, their conversion to electronic format and their archive and storage, ensuring they are easily retrievable in a manual document control system.

Effectively and Timely retrieve and archive old versions.

Effectively Route, interface with individuals and track documents for timely approval.

Maintain Daily accurate Master SOP list and other logs and related databases.

Effectively and Timely performed periodic review updates of existing SOPS.

Timely responded to requests for information specific to the Quality System documents.

Successfully prepared spreadsheets for the transferring of information for approximately 1500 documents from the manual system into the Agile PLM System.

Musculoskeletal Transplant Foundation, Edison NJ 2000 – 2012

Manager, Document Control Department

Responsible for the system administration, validation and performance of an FDA regulated document control system. Lead a team of six (6) employees responsible for the daily routing of documentation.

Responsible for ensuring correct formatting, approval and review of over 80,000 documents in addition to a yearly addition of approximately 6000 records.

Archived 100% turn-around of priority documents within twenty-four (24) hours and 90% routing of normal priority documentation within ten (10) working days from the day of submission.

Trained personnel on utilization of the document system providing instruction on how to utilize the Master Control System.

Created and established over sixty (60) Department Document Matrices identifying user document training for over 1500 employees.

Established document competence training for over 1200 employees in less than three (3) months.

Document Control Coordinator (2000 – 2003)

Lead other team members with daily work production in the electronic system. Aided with training, resolving problematic issues with formatting, use of document templates, approval and review of document routings.

Manually transferred approximately 1500 documents into an FDA regulated electronic system in less than one (1) month while concurrently approving and reviewing documentation manually.

MOBIL CHEMICAL Co, Research Laboratory, Edison NJ 1987 – 2000

Senior Research Technician

Trained peers and interacted it with vendors in the debugging of instrument software. Supported Pilot Plant endeavors and provided necessary coverage during trial runs.

Compiled and managed a sophisticated database that provided density, melt index and extrusion properties of resins needed to guide, support and run pilot plant reactors.

Instituted and managed a highly successful site weathering testing program that opened the sales market for TREX products nationally and internationally.

Personal Products J&J, R&D Laboratory, Milltown, NJ 1985-1987

Research Technician

Supervise a group of 25 temporary personnel at the pilot plant facility monitoring the hand made production of new trial products.

EDUCATION

A.A.S Chemical Technology, 1986

Middlesex County College, Edison New Jersey

Recipient of “Alice Jackson Stuart Award” for Academic Excellence

TECHNICAL TRAINING

Microsoft Office Suite

People Soft and InfoMed

Master Control Document System compliant with regulation 21 CFR Part 11

Agile PLM & MAP Agile Document Systems

Experience with GMPs and ISO – 9000 standards

Fluent in verbal and written Spanish

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