CLAUDETTE MATIZ
Groton,MA
Summary
Quality-driven Systems and Compliance Specialist with extensive expertise in documentation, training, and records management. Recognized for exceptional attention to detail and strong organizational skills, contributing effectively in both collaborative and independent settings. Proven ability to manage multiple projects simultaneously while maintaining high accuracy and prioritizing tasks to meet deadlines. Committed to ensuring operational efficiency and upholding compliance standards.
Overview
28
28
years of professional experience
Work History
Quality Systems & Compliance Specialist
Takeda Pharmaceuticals
10.2019 - Current
- CAPA management
- Support internal and external audits/inspections
- Support/Complete pre-migration tasks in the implementation of global DMS Veeva and LMS (SuccessFactors)
- Prepare KPI metrics for CAPAs, Training and Gap Assessments
- Business Admin (BSA) for DMS and LMS Admin
- Support Product Quality Reports (PQR)
- Support Yearly Biologic Product Reports (YBPR)
- Support/Manage Records Management/Archiving process
Manager I
Takeda Pharmaceuticals
06.2014 - 10.2019
- Assist in the implementation of a global document & learning management system (LEADs)
- Regional Business System Administrator for LEADs (DMS and LMS) for TBOS, TPUSA and Brooklyn Park
- Manage successful R&D transformation/integration submission project into EDCS
- Prepare metrics for multiple business units
- Manage departmental portal and teamsites using MS Sharepoint
- Create Sharepoint forms for document/record submission process
- Manage transition projects after implementation of global LEADs (including creation/revision of procedures)
- Manage departmental EMRs and CAPAs in Trackwise
- Manage and submit Periodic Reviews in LEADs
- Manage controlled document Internal/External Manual distribution process to external partners
- Manage Documentation and Archiving personnel
- Participate in internal audits / inspections
Quality Assurance Specialist III
Takeda Pharmaceuticals
02.2010 - 06.2014
- Managed continued compliance for EDCS and MyEDCS and associated version releases
- Managed multiple projects including bulk document submissions into EDCS
- Assisted in Document Practices project which included revision to document templates
- Created Survey in MS Sharepoint & rolled out to users of the EDCS system
- Streamlined departments MS Access databases into one central file location
Quality Assurance Specialist II
Millennium: The Takeda Oncology Company
01.2008 - 02.2010
- Created monthly statistical reports using MS Excel and Word
- Assisted with multiple projects including Scanning Solution & MyQUMAS
- Revamped/Manage the departments MS Access databases
- Managed Expiration Date Reviews for all controlled effective documents in EDCS
- Managed the QA Documentation Portal & EDCS Teamsite using MS Sharepoint
- Performed all tasks associated with being an EDCS Business Administrator
- Managed assigned workflows using the EDCS application
- Assisted with the implementation of converting the QFR to an electronic QFR
- Completed test scripts part of the EDCS application
- Assisted with the implementation to convert external manuals into virtual binders using EDCS
- Streamlined the process of EDCS document submissions by creating eEDCS Information Sheets
Quality Assurance Specialist I
Millennium Pharmaceuticals, Inc
01.2006 - 01.2008
- Managed Controlled Documentation Report Numbering spreadsheet
- Performed monthly audits to ensure documents submitted to the QFR are reconciled in an Excel spreadsheet
- Assisted the team to re-configure EDCS User training utilizing Breeze and writing scripts
Contract Documentation Assistant
Abbott Personnel Consulting
10.2005 - 12.2005
- Contracted position with Millennium Pharmaceuticals in Cambridge, MA
- Managed all document submittals and retrievals via the Quality File Room (QFR)
- Updated Access database with all requests to the QFR
Contract Database Admin
Abbott Personnel Consulting
11.2004 - 09.2005
- Contracted position with Millennium Pharmaceuticals in Cambridge, MA
- Scanned protocol documents into Pdf
- Assisted with organizing the network drive
- Assisted in the migration/curation of the new MS Access Database to track all protocol data
- Assisted with misc. projects for Clinical dept.
Web Administration
Cedar Point Communications
01.2003 - 11.2004
- Develop & maintain content posted to the intranet & website using Dreamweaver
- Development of the HR & Sales Intranet sites
- Revamping of the Marketing Intranet site
- Edit graphics/photos using Photoshop & Illustrator
- Convert Word Documents into PDF
- Create forms using Adobe Acrobat
- Prepare weekly web reports using Webtrends
Contract Marketing Professional/Call Rep
Linkage, Inc
09.2004 - 10.2004
- Perform sales calls to Senior Level Executives to qualify their interest in attending a Sales & Marketing Leaders Summit sponsored by Linkage
- Maintain database using SalesLogix
Administrative Assistant
Cedar Point Communications
01.2001 - 01.2003
- Managed Shipping & Receiving Department
- Managed reception area, switchboard & inventory of office supplies
- Provided assistance to the Accounting Department with invoicing procedures
- Assisted Marketing department with preparation for tradeshows & offsite events
- Maintained Marketing page on the corporate website using Dreamweaver
- Managed all corporate travel & meal arrangements including onsite & offsite meetings
- Designed & implemented an MS Access database to track corporate agreements
- Managed resumes & evaluations in the corporate database
Administrative Assistant
Lucent Technologies
09.1998 - 12.2000
- Provided administrative support to 5 Technical Managers & 50 Engineers
- Prepared MS Excel spreadsheets, Word documents & PowerPoint presentations
- Managed Quality Documentation Center (QDC) contact for multiple organizations
- Prepared journal & purchase orders
- Coordinated travel arrangements, business meetings onsite & via video conferencing
- Managed departmental activities within Lucent & offsite
Education
Bachelor of Science - Information Sciences and Technology
Endicott College
Beverly, MA01-2004
Certification - Webmaster
Merrimack College
North Andover, MA01-2001
Skills
- QUMAS Products (DocCompliance & MyQUMAS) (internal names EDCS/LEADs), Veeva, NetDimensions (Learning Management System (LMS)), Trackwise, ServiceNow (IT ticket system), SAP SuccessFactors
- Microsoft (MS) Office (Access, Excel, Outlook, PowerPoint, Publisher, Visio, Word), MS SharePoint, Adobe Acrobat, Snagit Editor, Content Manager
Accomplishments
Earned multiple recognition awards over the years for outstanding contributions in Documentation, Training, Regulatory Inspections, and Testing activities supporting new system implementations.
Timeline
Quality Systems & Compliance Specialist
Takeda Pharmaceuticals
10.2019 - Current
Manager I
Takeda Pharmaceuticals
06.2014 - 10.2019
Quality Assurance Specialist III
Takeda Pharmaceuticals
02.2010 - 06.2014
Quality Assurance Specialist II
Millennium: The Takeda Oncology Company
01.2008 - 02.2010
Quality Assurance Specialist I
Millennium Pharmaceuticals, Inc
01.2006 - 01.2008
Contract Documentation Assistant
Abbott Personnel Consulting
10.2005 - 12.2005
Contract Database Admin
Abbott Personnel Consulting
11.2004 - 09.2005
Contract Marketing Professional/Call Rep
Linkage, Inc
09.2004 - 10.2004
Web Administration
Cedar Point Communications
01.2003 - 11.2004
Administrative Assistant
Cedar Point Communications
01.2001 - 01.2003
Administrative Assistant
Lucent Technologies
09.1998 - 12.2000
Certification - Webmaster
Merrimack College
Bachelor of Science - Information Sciences and Technology
Endicott College
AWARDS/MEMBERSHIPS/VOLUNTEER WORK
2006-Present Millennium/Takeda – Multiple STAR/Recognition Awards received, 2017 Takeda – Exceptional Recognition award received, 2005 – Youth Organization Leader, 2000 Lucent Technologies – Certificate of Appreciation from Systems Standards Engineering, 2000 Lucent Technologies – Recognition Announcement from Configuration Group, 2000 Executive Board Member of Women in Leadership at Lucent (WIL-MV)