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Document Control Specialist

Milpitas, CA
April 16, 2024

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

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

7/20 – Present Thermo Fisher Scientific – Santa Clara, CA Quality Document Control Specialist– Responsible for processing ECOs using Agile PLM and Intuitive ERP systems. Collaborate with ECO originators to compile required ECO content. Assist new users with Agile training and guidance. Strong emphasis on documentation and change control processes utilizing GDP in an ISO13485 environment. Sustained bi-annual reviews of QMS SOP and WIs for accuracy. Assigned and tracked employee training using SAP Success Factor Learning Management System

8/19 – 11/19 Thermo Fisher Scientific (Contractor) – Santa Clara, CA Document Control Specialist– Contract position responsible for processing ECOs using Agile PLM and Intuitive ERP systems. Cleared backlog of 160 ECOs in process and maintained data to show streamlined process.

12/18 – 8/19 - Milpitas, CA

Parental Caregiver

Details upon request

12/17 – 12/18 D.I.S. - Milpitas, CA

Document Control Administrator – Responsible for overseeing the Document Control Department and recommending new processes to streamline ECO turnaround times. Also reorganized QMS documents, structured Quality Records storage and tracked employee training. Wrote department SOPs and Work Instructions for Epicor system usage. Wrote and performed group training documentation. Also maintained calibration system and recall lists for machining tools and equipment. Part of the new system configuration team to determine required attributes for change control.

10/17 – 12/2017 Deliv (Contractor) - Menlo Park, CA Documentation Reviewer/Operations Representative– Seasonal position to review required documents (licenses, registrations, insurance policies) for on-boarding drivers to partner with same-day delivery service. Also resolve driver inquiries for on boarding and scheduling via helpdesk tickets and phone support. Triage driver issues with phone app and delivery specifics 08/16 – 09/17 Caregiver - Milpitas, CA

Details upon request

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01/16 – 08/16 Intersect ENT (Contractor) – Menlo Park, CA Sr. Document Control Specialist– Process Change Orders, assist in writing SOPs, log and track employee training matrices, issue part numbers and distribute controlled copies to clean-rooms.

06/15 – 11/15 Vention Medical (Contractor) – Sunnyvale, CA Document Control Specialist – Maintain all Document Control Quality System and Training content including preparation to convert paper-based system to software. 12/13 – 06/15 Abbott Medical Optics (Contractor) – Milpitas, CA Sr. Change Analyst – Contracted for Integration project for a company recently acquired by Abbott. Created items and changes from Arena system to Agile v9.3 system. Also writing all levels of Agile v9.3 training slide decks for all User Training.

07/12 – 11/13 Stryker Neurovascular (Contractor) – Fremont, CA Promotional Materials Documentation Specialist – Converted SOP and Work Instructions from acquired Boston Scientific to Stryker formatting. Transferred to Promotional Materials Documentation Specialist where I processed Quality Document releases for Marketing materials and Physician Presentations using a paper-based system. 08/11 – 07/12 Apple (Contractor) – Cupertino, CA

WPCM Change Analyst and 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

(Worldwide Product Configuration Management) documentation within Agile and WPCM Knowledge Base Wiki. Attended weekly CCB meetings to incorporate PLM changes that reflect department and training documentation.

01/11 – 08/11 St. Jude Medical (Contractor) – Irvine CA Documentation/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 – 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 – 01/10 Spineview – (Consultant) – 48541 Warm Springs Blvd, Fremont CA ECO Change Analyst- Performed ECR Processing, Technical Writing for Standard Operating Procedures, and updates to CAD drawings. Also organized training records and participated in Regulatory Compliance audits.

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08/05 – 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 Preventive Action) which includes chairing CAPA board meetings and assisting CAPA owners in writing investigations, action plans and effectiveness reviews.

01/05 – 08/05 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).

05/00 – 12/04 Fiberstars – 44259 Nobel Drive, Fremont CA Document Control Specialist/ECO Change Analyst - 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. EDUCATION – GED, Milpitas Adult Education, July 1992 Mission College, Santa Clara, June 1994

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