Assistant Manager

Alma R. Sanchez

Oakland, CA ***** 510-***-**** ************@*****.***

http://www.linkedin.com/pub/alma-r-sanchez/6/770/4a7

Qualifications

Detail-oriented Documentation Specialist with 15+ years of progressively responsible experience in project management and QA documentation in Good Manufacturing Practices (GMP) environments. EDMS workflow administrator for the Meridian database, including ECO, document/drawing cataloging, tracking, reporting, distribution and archiving. Strong organizational, written, and verbal communication skills.

Able to handle multiple tasks and priorities in a fast-paced environment. Works independently and as part of a team to determine priorities, track progress, and report project completion status. Fluent in Spanish.

Technical Summary

Microsoft Office, Microsoft Outlook, Adobe Acrobat, Adobe Capture, Live Link, Meridian Database. Familiarity with large format copiers and scanners. Compliant with FDA and ISO.

Experience

Bayside Solutions, Pleasanton, CA

2011 to Present

Document Control Specialist, contract at Xoma

Process Document Change Request. Assist with revisions to GMP workflows in the electronic documentation system. Revise and implement Controlled Documents including SOPs, BPR’s, Specifications, Test Methods and Archive submissions. Process electronic documentation system workflows. Maintain Document Control/Archive room

Novartis Vaccines & Diagnostics Inc., Emeryville, CA

2007 to 2011

Documentation Project Specialist II

Maintained 10,000+ Engineering Controlled Documentation hard copies and electronic copies related to GMP and Non-GMP facilities critical equipment and utilities systems per SOP and ISO requirements

Provided technical expertise for the development of user and functional requirements and execution of validation test scripts for the Meridian Database

Managed a 21 CFR 211 compliant database of thousands of documents to ensure effective and accurate entries and workflows of engineering document change orders and associated documents

Provided document support to entire Novartis Emeryville campus, supporting both internal and external stakeholders

Collaborated with manager and CAD operator to create first draft of controlled user guide on Meridian Database. Served as SME during subsequent revisions of same document

Acted as SME and partnered with in-house IT representative to resolve issues within the Meridian Database

Managed the scanning of all facilities related documentation for both GMP and Non-GMP hard copy systems/equipment facilities manuals for disaster recovery purposes and for uploading and viewing accessibility

Trained and supervised temporary staff and summer interns on office procedures and database procedures and needs

Novartis Vaccines & Diagnostics Inc., (formerly Chiron) Emeryville CA

1994 – 2007

Documentation Assistant III / Documentation Assistant I

Tracked over 40,000 GMP documents for the BioPharma and Blood Testing Divisions

Provided documentation for significant multiple sclerosis filing

Admin Assistant

Provided general clerical assistant for Corporate Engineering personnel

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