Objective

Document Control professional seeking a position in a company that endorses development, grants opportunity for advancement, and provides employment stability. Team-oriented individual who embraces challenges that allow further utilization of current skills and acquisition of new responsibilities and experience.

Experience

Abbott Diagnostics January 2019 – August 2019

San Diego, CA

Document Control Specialist II

Process incoming Change Requests in Agile PLM

Create Engineering and QMS Change Orders in in Agile PLM

Follow up on change actions such as Training, Risk and DMR Assessments

Compile data for the creation of metrics and reports for various departmental activities.

Carry out the daily activities of the Document Control function and supports project teams in meeting quality and business objectives as they relate to product life cycle management and document control.

Track the change process through development, approval, and implementation.

Analyze and interpret the significance of the proposed change, supporting data and approval requirements on a case-by-case basis.

Ensures changes and documentation comply with the company's policies and procedures.

Tandem Diabetes Care, Inc. February 2014 – August 2016

San Diego, CA

Document Control Specialist II

Responsible for the daily process, coordination and timely release and implementation of Change Orders and administrative documents in Master Control (EDMS).

Reviewed documentation of diverse scope, parts and BOMs for adequacy, correct template, format, revision, approval workflow and lifecycle.

Assigned corresponding training of released and revised documentation to affected groups.

Functioned as lead in support of various documentation projects, ensuring their timely release and implementation.

Maintained DHFs and other quality records in Master Control.

Issued document and part numbers.

Responsible for assigning lab notebook numbers as well as retrieval, archival and data maintenance.

Ensured prompt and accurate filing, distribution, retrieval and archival of controlled documents and other quality records as well as maintenance of company’s database record retention entries.

Acted as company key contact with document off-site storage service provider.

Assisted with maintenance of employee-training records in EDMS.

Provided user training of EDMS system on an as-needed basis.

Monitored, investigated, and troubleshoot user-related software issues on EDMS and recommended possible solutions.

Supported the implementation activities of Agile PLM (EDMS), such as software user acceptance testing and data migration from Master Control.

Participated in the creation of Tandem’s document control procedures.

Reviewed and updated document control procedures to reflect current processes and practices.

Assisted with periodic audits of documents and records to ensure regulatory compliance.

Assisted and participated in external audits such as ISO audits and regulatory inspections as functional area representative.

Supported QA manager with administrative tasks of Internal Audits and CAPAs, such as follow up, data entry log and maintenance, compiling verification of effectiveness for QA manager review, scanning, closing, and filing.

Under the guidance of lead auditors, assisted and participated in the execution of Internal Audits.

Prepared document control monthly metrics.

Performed duties in compliance with applicable FDA and state, legal and safety regulations.

Other QA and administrative duties as assigned.

NuVasive, Inc. May 2012 – February 2014

San Diego, CA

Document Control Analyst

Provided administrative support of the day-to-day operation of Document Control department.

Reviewed for adequacy, processed, and coordinated ECO approval and release of diverse documentation, as well as materials and BOMs submitted through SAP.

Assigned corresponding training of released and revised documentation to affected groups.

Ensured proper distribution, retrieval and archival of controlled documents and other quality records.

Troubleshoot Document Control issues pertaining to document requests and customer inquiries requiring analysis of data.

Assisted with maintenance of DHRs and Quality Records according to NuVasive’s record retention policy.

Assisted and participated in external audits such as ISO audits and regulatory inspections as functional area representative.

Responsible for document, part, and lot number assignation.

Active participation in the creation of Nuvasive’s document control procedures as well as update of the document control procedures to reflect current processes and practices.

On a regular basis, collaborated with the information technology (IT) department to test the EDMS engineering change order environment for upgrades and workflow improvements.

Provided administrative support to Quality Engineering Department, as required.

Performed duties in compliance with applicable FDA and state regulations.

Education

Montgomery High School - High School Diploma,

1992 – 1996

Certifications

CQIA- Quality Improvement Associate, American Society for Quality June, 2013

Certification designed to test basic knowledge of quality tools and their uses, along with involvement in quality improvement projects.

Skills

Experience in FDA/ISO regulated facilities.

Technical Translator (Spanish/English) for Medical Device/Biotech and Electronics documentation.

Full understanding of most EDMS software systems (SAP, Master Control, Agile PLM, QCBD, Track Wise, CRM, Documentum and SharePoint).

Expert in Microsoft Office applications (Word, Excel, PowerPoint, VISIO, Microsoft Lync and Outlook).

Proficient using Adobe Acrobat Pro (.pfd editing), Solid Works and AutoCAD (read only)

Proficient using Internet web browsers search engines as well as general office equipment, such as computer, telephone, copier, scanner, fax, printer, calculators.

Excellent communication skills and good customer service relations and rapport.

Go-to-person, organized, detailed-oriented and self-starter.

Excellent interpersonal skills, phone manner, and office etiquette.

Efficiently work independently with minimal supervision.

Multi-task concurrently with impeccable quality results.

References

Upon request.

Contact this candidate