Technical Writer, Change Management

RHONDA ELLIS

**** ********* *******, *******, ** 94538

Mobile: 408-***-****

Current Office: 408-***-****

********@*****.***

OBJECTIVE: Seeking a challenging position in a quality conscious environment where organizational, communication, technical and writing skills can be utilized.

EXPERIENCE:

08/11 – present Apple (Contractor) – City Center One, Cupertino, CA

WPCM Technical Writer – Filled an immediate need to create and revise existing Agile Training curriculum to accommodate new User Interface for PLM. Agile Training Team demonstrator for scheduled Agile PLM training classes. ECR Analyst for existing WPCM documentation within Agile and WPCM Knowledge Base Wiki

01/11 – 8/11 St. Jude Medical (Consultant)– 2375 Morse Ave., Irvine CA

Technical Writer – Consulting project to update Manufacturing Instructions for Class 3 Medical Device (catheter) company. Observed and documented current Clean Room processes and performed major rewrites for internal documents (SOPs and Work Instructions).

01/10 - 07/10 Optovue – 45531 Northport Loop W., Fremont CA

Document Control Specialist – Issue, process and implement ECR /ECO using Windchill. Analyzed change requests and issued tasks accordingly. Chaired weekly CRB (Change Review Board) meetings, created / updated SOPs and Work Instructions within Quality System to regulatory standards.

11/09 – 1/10 Spineview – (Consultant)– 48541 Warm Springs Blvd, Fremont CA

Document Control Consultant - Performed ECR Processing, Technical Writing for Standard Operation Procedures, and updates to CAD drawings. Also organized training records and participated in Regulatory Compliance audits.

8/05 – 04/09 W.L. Gore & Associates – 1327 Orleans Dr. Sunnyvale CA

Document Controller/ CAPA Coordinator – Issue, process and implement NOC (Notice of Change) for FDA regulated Medical Products. Assist originators with assessing levels of changes, the corresponding attachments that apply, and creating and revising SOP’s, Solidworks and AutoCAD drawings. Generate changes in FileMaker, Agile 9.1 and Oracle systems. Sustain new product documentation for clinical trials and maintain hardcopy and softcopy file storage for restricted documents utilizing all GMPs (Good Manufacturing Practices). Also accepted commitment to coordinate CAPA (Corrective and Preventative Action) which includes chairing CAPA board meetings and assisting CAPA owners in writing investigations, action plans and effectiveness reviews.

1/05 – 8/05 Pinnacle Systems – 280 N. Bernardo Ave., Mt. View CA

Sr. Document Control Administrator – Defined department procedures and created Standard Operating Procedures for ECO, Part Numbering, and Material Master Requests processes. Performed standard ECO Analyst duties including ECO writing, BOM redlining and updating, and material dispositions to generate Engineering Change Orders for new and existing products using SAP System. Performed RoHS WEEE part number compliance tasks. Created manufacturing process procedures (specifically packaging procedures for Contract Manufacturers and ECO distribution methods).

5/00 – 12/04 Fiberstars – 44259 Nobel Drive, Fremont CA

Document Control Specialist - Responsibilities included preparing documentation for new product releases, and processing changes to existing product lines. Analyzed ECO requests and prepared redlined documents for sustaining engineers. Also created and updated Bills of Material in Expandable II per ECO guidelines, input initials on drawings in AutoCAD & Solidworks, assigned part numbers, copied and distributed documents, created department purchase orders and generated weekly purchase reports, Processed internal Materials Requisitions and receiving documents. Maintained weekly CCB updates and chaired weekly CCB meetings. Controlled electronic files for all preliminary and released products. Assisted with creating product instruction manuals as needed. Managed a high volume of engineering change requests with minimal supervision.

8/97 – 4/00 Oz Tek - 3387 Investment Blvd., Hayward CA

Document Control / Technical Writer – Write departmental work instructions and corporate procedures within a Document Control environment. Manage electronic files and generate revisions for Engineering Change Orders, Bills of Material, Policies / Procedures, Product Drawings and Specifications. and their revisions. Manage high volume of custom product requiring multiple updates and changes using Microsoft Word, Excel and Autocad software.

REFERENCES Available upon request

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