Document Control Quality Assurance

Dedicated and detail-oriented professional with extensive experience in Document Control with ISO9001 and ISO13485 and other Quality areas specializing in the Medical Device industry and pharmaceutical construction.

EXPERIENCE:

Sartorius Stedim North America 05/2020 – 07/2024

Documentation Validation Specialist (ISO 9001 environment)

Digital Conversion: Collaboratively worked with internal Document Control Leads and an external team to redevelop project structures and turnover packages for a digital environment, achieving a 90%-time savings resulting in a financial saving of $100,000 over the course of six months.

Collaborative Projects: Foster effective collaboration with project managers, customers, and vendors leading to successful project outcomes.

Budget and Time Management: establishing strong project management skills by vigilantly ensuring that documentation support activities are completed within the allocated time frame and budget.

Quality Assurance: Perform detailed QA/Documentation reviews for all system Turnover package documentation.

Project Documentation: Closely collaborate with project managers and engineering support teams ensuring accuracy and clarity.

Change Control: effectively participate in change control processes regarding documentation flow for Turn-over Packages, contributing to continuous process improvement.

Turnover Package Management: Compile, control, and disseminate Turnover Packages in strict accordance with the standard operating procedures, ensuring accuracy and completeness.

Mentorship: Mentor and train personnel in documentation management, fostering a culture of knowledge sharing and professional development.

SOP: Development of Internal Standard Operating Procedures and Work Guidelines.

Document Archiving: Scanning, reviewing, logging and storage: electronic and hardcopy. I am the account manager for Iron Mountain at my facility.

Pall Corporation

Documentation Validation Specialist (ISO 9000 environment)

Consultant 09/2015 - 01/2016

Direct 01/2016 - 05/2020

Collaborative Projects: Foster effective collaboration with project managers, customers, and vendors leading to successful project outcomes.

Budget and Time Management: establishing strong project management skills by vigilantly ensuring that documentation support activities are completed within the allocated time frame and budget.

Quality Assurance: Perform detailed QA/Documentation reviews for all system documentation.

Project Documentation: Closely collaborate with project managers and engineering support teams ensuring accuracy and clarity.

Change Control: effectively participate in change control processes regarding documentation flow for Turn-over Packages, contributing to continuous process improvement.

Turnover Package Management: Compile, control, and disseminate Turnover Packages in strict accordance with the standard operating procedures, ensuring accuracy and completeness.

Document Archiving: Scanning, reviewing, logging and storage: electronic and hardcopy. I am the account manager for Iron Mountain at my facility.

Mentorship: Mentor and train personnel in documentation management, fostering a culture of knowledge sharing and professional development.

Consultant Positions 02/2010 – 07/2015

Atrium Medical

Change Analyst

Revise MP/QP/TPs and the documents maintained within the quality system.

Utilizing company-standardized templates as well as documentation management.

Worked alongside QC, QA and Originators to achieve all deliverables.

BioDetek

Agile Administrator

Train team members in Agile program and practices.

Teleflex, Inc.

Project Manager of Special Projects

Supervised team: Project to harmonize the documentation standards and processes across multiple facility locations, following the best practices of the Chelmsford Massachusetts location

Documentation Manager

Assisted in Development and maintenance of the Preventative Maintenance System documentation for Production Equipment.

Assisted in Preventative Maintenance System for the overall facility including writing procedures customized to business sites and release of documentation.

Managed Electronic documentation in Agile.

Managed hard copy documentation

VCE

ECO Coordinator

Managed Electronic documentation in Arena.

Managed hard copy documentation

Cadence Inc.

Process Planner

Managed Electronic documentation.

Managed hard copy documentation.

Implemented Routers for manufacturing with detailed instructions

Anvil International, Inc.

Documentation Site Designer

Transition the company to a digital environment

Develop a digital Document Management System and foster Implementation.

Train associated on new document management system

UNFI

Document Control Coordinator:

Develop and manage digital documentation system

Train associated on new document management system

The Shaw Group Inc. 06/2007 – 04/2009

Manager: Document Control 08/2008 - 04/2009

Lead Document Control Management Specialist 06/2007 – 08/2008

EDUCATION:

Community College of Rhode Island, Warwick, RI

Courses towards degree: Business & Psychology

ACTIVITIES:

Psi Beta Honors Society President

PROFESSIONAL ACTIVITIES:

Safety Committee

Sustainability Committee

Event Committee – Chairperson

SOFTWARE PROFICIENCY:

Advanced skills: Microsoft Office products Arena Documentum

SharePoint Agile SAP

Adobe Products Vault Confluence (Company Wiki site)

*References available upon request

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