Geraldine McCarthy
Haverhill,MA
Summary
Seasoned, motivated, dedicated and experienced professional with background in several regulated industries.
· Wireless Telecommunications
· Healthcare Industry / IT Software Validation
· Document Management / Control
· Information Technology System Security
Continually acquired new skills that allow me to adapt to the changing industry. Demonstrated the ability to interface effectively with all levels of management.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Quality System Specialist
Philips Healthcare
01.2015 - 06.2023
- Validation Document & Record Specialist,
- Quality Specialist
- Agile Change Analyst Role,
- Business Unit Owner Role
- PPM Rating Strong performer & Role Model
Manufacturing Engineering Assistant
Hologic Inc.
06.2014 - 12.2014
- Direct support to Manufacturing Engineering team, additional support to product labeling team
- Direct contributor to the successful completion of UDI Compliance Project to register all Class III Medical Devices with FDA in GUIDID registry database with Unique Device Identification
- Project support – review, development and processing of new label releases for (GHS) Global Harmonized System Project
- Agile authoring of change orders and updating product BOMs
- Ancillary projects as needed.
Project Coordinator
Philips Healthcare
01.2010 - 01.2013
- Validation Document & Record Specialist,
- Quality Specialist
- Agile Change Analyst Role,
- Business Unit Owner Role
Project Coordinator
RSA Security Division of EMC
01.2007 - 01.2008
- Successfully met quarterly division financial goals of 1 million plus over 3 consecutive quarters.
Site Acquisition Administrator
Alcatel-Lucent Technologies
01.2006 - 01.2006
- Directly assisted Site Acquisition Manager in day to day reports, drafted correspondence and provided highly diligent follow up on specific problems.
Site Acquisition Administrator
Lucent Technologies
01.2005 - 01.2006
- Researched Site Files and performed Lease Analysis Reports to determine lease terms
- Assembled 200 + Close-out Binders.
Zoning Administration Specialist
Mac Tec
01.2005 - 01.2005
- Prepared zoning applications, building permits and letter correspondence
- Tracked zoning and permitting processes of site candidates and created reporting documents of certain project milestones
- Cross Referenced multi-site legal opinions on jurisdictional filing requirements.
Project Administration Specialist
Nextel
01.2004 - 01.2005
- Maintained two Master Site Trackers.
Zoning Research Specialist
Ericsson
01.2004 - 01.2004
- Determined local requirements, policies, procedures and relevant zoning and permitting information
- Performed zoning and permitting/ feasibility analyses of all jurisdictional land-use and building code regulations for site candidates.
Document Coder/Quality Controller
CACI
01.2003 - 01.2004
- Public Trust Security Clearance
- Coded approximately 300 documents per day according to bates numbers
- Performed Quality Control Review on coded documents both hard/soft copies
- Assembled documents using automated document image indexing system.
Document Regulatory Compliance Specialist
LCC International, Inc.
01.1998 - 01.2002
- Promoted to Zoning Specialist – XM Satellite Radio Project
- Project Coordinator, National Level
- Project Coordinator – e.Spire
- Administrative Assistant – Various Projects.
Education
MassSTEP, IT Support Specialist Program in Information Technology -
North Shore Community College
gmccarth02@Northshore.edu06.2024
Skills
- Quality Management Systems
- Document Control
- Customer Service
- Performance monitoring
- Team Collaboration
- Process Documentation
- Lean Manufacturing Methodologies
- Effective Multitasking
- Continuous Improvement
- Analytical Skills
- Attention to Detail
- Problem-solving abilities
- Employee Training
- Specification Review
- Agile Software Validation Methodologies
Computer And Database Skills
- Orbus iServer
- ValGenesis
- TEDS Learning Management System /Training Management Systems
- Business Objects
- Qlik Sense Reporting Hub
- Workday
- ARIS PEPF Portal
- KPI & Control Tower Monthly reporting
- Agile PLM System – Product Lifecycle Management or Document Lifecycle Management –ECOs, MCOs, SCOs, BOMS
- Agile PLM System – Document Lifecycle Management –Doc UX QS and ER workflows
- TrackWise
- SharePoint
- Global Clarify
- Customer Feedback Management Systems / CFM Portal / Amdocs
- Field Scheduling Tool – FST
- Siebel
- Caspr/Siterra
- MS Office Professional Suite - Strong in Excel & Word
- Microsoft TEAMS
- Microsoft Forms
- Outlook & Project Schedule Management
- Google suites
Certification
- CyberSafe Certification, CertNexus, 05/2024
- IT Service Desk: Customer Service Fundamentals, Linkedin Learning, 05/2024
- Customer Service: Problem-Solving, Troubleshooting, Linkedin Learning, 05/2024
Areas Of Effectiveness
- Software Lifecycle Validation Protocol Deliverables Development, Testing and Review.
- Document Management / Records Control
- End to End Wireless Project Management and Support
- Accounts Payable Receivable and Invoicing
- Scheduling
- Highly detail oriented
- Strong work ethic, flexible and calm under short deadline or shifting priorities.
Timeline
Quality System Specialist
Philips Healthcare
01.2015 - 06.2023
Manufacturing Engineering Assistant
Hologic Inc.
06.2014 - 12.2014
Project Coordinator
Philips Healthcare
01.2010 - 01.2013
Project Coordinator
RSA Security Division of EMC
01.2007 - 01.2008
Site Acquisition Administrator
Alcatel-Lucent Technologies
01.2006 - 01.2006
Site Acquisition Administrator
Lucent Technologies
01.2005 - 01.2006
Zoning Administration Specialist
Mac Tec
01.2005 - 01.2005
Project Administration Specialist
Nextel
01.2004 - 01.2005
Zoning Research Specialist
Ericsson
01.2004 - 01.2004
Document Coder/Quality Controller
CACI
01.2003 - 01.2004
Document Regulatory Compliance Specialist
LCC International, Inc.
01.1998 - 01.2002
MassSTEP, IT Support Specialist Program in Information Technology -
North Shore Community College
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