Kimberly_S_Gilbert_Resume

Kimberly Gilbert2097 Sheridan Court, Simi Valley, CA 93065

Cell: 805-501-4593 [email protected]

Summary:Dedicated and focused Coordinator who excels at prioritizing, completing multiple task simultaneously and following through to achieve project goals. Seeking role of increased responsibility and authority.

Accomplishments• Oversaw implementation of new Research automated drop off of supplies.• Successfully trained staff in MasterControl (office system) and policies while focusing on

minimizing errors and generating superior results.• Planned training for Amgen Management Essentials Program (AME) for all Directors and

Executive Directors per CEO requested training.

EducationAssociate of Arts: General Studies - May 2013Moorpark College – Moorpark CA

Experience:Document Control Associate – April 2011 to August 2015One Lambda Inc. part of Thermo Fisher Scientific, Canoga Park CA

• DCRs (Document Change Request), initiate, coordinate, release collaboration tasks of assigned documents within Master Control in accordance to the request.

• Formatting and editing of final drafts before sent to approval• Process and release label request for Quality review• Assisted Engineering Department in Master Control project to upload all current and archived

AutoCAD drawings.• Trained in system administrator function as backup in creating Organizers, Imports, and training

tool.• Designed electronic file system (MasterControl) and maintained electronic and paper files.• Volunteer on the Employee Event Committee.

Document Control Associate – January 2011 to March 2011One Lambda Inc. Canoga Park CA

• Please see description of full time position. This was a Temp to Hire position

RA/QA Coordinator/ Controlled Documentation – October 2009 to April 2010Implantech Associates Inc. (Quest), Ventura, CA

• Quality Control for all regulatory affairs documents and work orders• Procedure writing for MRP Plus system• Complete spreadsheet for all product rejects• Distribute work orders as needed• Process request to the FDA for new updated Certificate of Foreign Government (CFG), process

returned CFG to Foreign Government for approval process, Completion process of Engineering Orders (EO) which includes: Form completion, draft completion from red lined document, route for signature approval, print and distribute an original copy for new or updated procedure, and train departments on new or updated procedure, release documents.



Lead Training Coordinator II / Project Coordinator – February 2008 to August 2009Amgen Inc. (SMCI), Thousand Oaks, CA

• Accountable for Amgen Management Essential Program (AME) which includes: creating timelines for the upcoming year for over 1000 participants

• Verifying accurate list of invited participants, email all communications to invited participants• Verify rater selection process is complete, survey process is complete, all classes are full by

following up with invited participants and running reports for HR Business Partners.• Manage AME no show/cancellation fees• Answer work orders for LMS training in Peregrine• Route role request and learning activities for LMS permissions via EDM Quality• Create internal audit procedure, performs monthly internal audit in LMS and EDM Quality• Approve requested training room bookings, create, curriculums, class and sessions within • Set up WebEx training for outside vendors

Document Control Coordinator/Jr. Technical Writer – December 2007 to April 2008Amgen Inc. (SMCI), Thousand Oaks, CA

• Coordinate and process controlled documents for Global ERP/SAP• Ensure correct template is used, formatting document before routing for approval, assist and

educate clients on DMS processes and EDM Quality• Verify approved controlled documentation to ensure they meet Corporate DMS standards• Obsolete requested documents in accordance with document owners

Jr. Technical Writer/Project Coordinator – July 2007 to November 2007Amgen Inc. (SMCI), Thousand Oaks, CA

• Ensure good documentation control practices are followed in the creation, handling, storage and maintenance of validation documentation

• Planned meetings and prepared conference rooms.• communicating with multidisciplinary teams to achieve project objectives within the tight time

frame, this involves logging risk and decision making into eRoom• Execution and report writing of Requirements, Requirements Traceability Matrix, Operational

Qualification, System Operating Procedures, and System Glossary documentation for GLP, GCP, GMP, GxP validated system within the 21 CFR part 11 guideline.

Controlled Documentation / Project Coordinator – July 2006 to June 2007Amgen Inc. (Kforce)

• Provided operational support for the of archival of submissions, controlled and verified the quality of submitted controlled project documentation deliverables

• Contributed to the improvement of the submission process for the Documentum (DECADE) to EDM Quality transition

• Regulated Information Systems documentation systems coordinator for the approving of completed controlled project documentation, maintained a detailed record of submitted controlled project documentation deliverables

• Coordinated the cross-departmental communication to resolve documentation issues, operated in accordance with department standard operating procedures and the regulations for GCP,GLP,GMP, GxP, SOX, and Infrastructure/Qualification, baseline (offsite) documents

• Assist in preparation for internal/external and FDA audits, maintained training compliance for the department

Skills



ISO 14385, 21 CFR part 11, GDP, GCP, GMP, GLP, Expense Reports, AutoCAD, Editing, ERP, SAP, Internal audit, Microsoft Outlook, Word, Excel, MRP, Peregrine, Procedure writing, Quality Control, Quality assurance, and MasterControl

Kimberly_S_Gilbert_Resume

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