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Gina Artalona

CAREER PROFILE

Professional Experienced Quality Assurance Auditor and Analysis with excellent qualifications in the following:

ISO9001:2015 Certified Lead Auditor ASQ - CAPA Certified Microsoft Applications Certified ASQ - Certified Quality Improvement Excellent Organizational Skills Superb Written/Verbal Qualifications Strategic Planning Superb Training/Developmental Skills NetSuite ERP PQCI - SQF Practitioner

Gemba, 5S, VSM, Kaizen, Lean Manufacturing CAPA, Value Stream Mapping, Problem Solving 8S, A3

PROFESSIONAL EXPERIENCE

Quality Compliance

Janssen Biotech, Inc. (Johnson & Johnson) 05/2022 - Current Overseen global gap assessment process

Performed gap assessments, from start to completion Internal Audit prep – COMET software

Identified and recorded Quality Investigations, audit findings, CAPA’s in TrackWise software Performed quarterly risk assessments

Updated and routed SOPs via TruVault software

Maintained and prepared gap assessment approvals

Overseen Mock Recall process

Obtained Supplier Quality approvals for global approved suppliers (ASL) Review and Updated Quality Agreements per procedural requirements Assisted in quarterly QMR meeting minutes

Created global training presentation and objectives Provided support multiple departments with obtaining supplier approvals Updated SMF (site master file)

Quality Assurance Documentation Control Specialist, Internal Auditor, SQF Practitioner Quality Pasta Company - Charleroi, PA 07/ 2020 - 04/ 2022 Managed Quality Management System Manual

Documentation Control of SOPs, Processes and Procedures Documentation Revision Control, MCI and Management of Records Overseen Non-Conformance and Quality Hold Log and finalizing dispositioning Sensory testing and Gluten Free Swab testing

Inventory Control

Created and maintained Yearly Internal Audit Schedule by Quarter Yearly Maintained Annual Training Matrix and Employee Training Records SQF Practitioner (secondary) Lean Internal Auditor New Hire Training and GMP training

Quality Assurance Analysis, Internal Auditor

A lli ed Ae ro fo am P ro d u c t s, LLC - Tam p a, FL 06 / 2016 - 05/ 2020

Created Implemented and Administered ISO 9001:2015 Quality Management System Created Companywide SOP, Process and Procedures

Performed Quarterly Internal Audits

Lead Investigation and Documentation of CAPAs

Identifying Root Causes and Performs Follow up Investigations Return Material Authorizations Internal Auditing/Training Responsible for Retention of Records/Documentation Control KPI Tracking/Reporting/Cost of Quality

Vendor Management review, performing Vendor Surveys and Voice of the Customer Safety Team Manager, Monthly Training Presenter

Project Manager Tampa Inventory

Quality Assurance Analysis/Documentation Control Administrator Leslie Controls, Inc. Circor - Tampa, FL 03/ 2010 – 09/ 2014 Developed Implemented and Administered ISO 9001:2008 Quality Management System Lead Auditor/Documentation Control

Created and Implemented Corporate Wide Export Compliance Manual Administrated and Created Internal Audit Plan

Company Processes and Standard Operating Procedures Created & Implemented Lead daily Gemba walk

ISO Business Swim Lane Flow Charts for Navy Front Line Improvement Plan Companywide Training on Quality Management System, Fraudulent Work Ethics and Importance of Quality Records for New Hire Orientation Staff Training Root Cause Analysis, 5 Why, Fishbone, A3

Identifying Root Causes and Performs Follow up Investigations Issuance and Investigation on CAPAs

Documentation Control and Record Keeping

Assisted Management Team with Interview Process/Group Interviews PricewaterhouseCoopers, LLP. - Pittsburgh, PA 06/2006 – 12/2009 Executive Team Assistant

Provided executive support to 4 Partners, 4 Senior Managers, 2 Directors 3 Managers and 8 associates for the audit committee (2 PwC client sites) Provided executive services including:

Maintained legal documentation supporting client sites. High volume executive scheduling and travel.

Overseen Time & Expense reporting as well as Budget to Actual reports. Maintain CPE compliance / WIP and billing support. PowerPoint Presentations, Budgeting Spreadsheets.

Executive administrative duties.

The University of South Florida, Tampa, FL 10/2003 - 02/2006 Executive Assistant Prodigy Cultural Arts Program Prodigy Cultural Arts Program Provided Executive Support to Director of Program and Grants and Director of Marketing. Maintained departmental agendas for corporate board meetings. Marketing Lead with Coordinated quarterly showcases. Assisted CFO with travel reimbursements.

Organized/Provided Weekly and Monthly Calendar Reminders. Created and Presented PowerPoint Presentations for website: Prodigy Webexone. Training Courses for Prodigy Website.

Audit Preparation Assistance for 12 Programs Yearly Audits. H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida Management Assistant III 09/1999 – 09/2003

Executive Assistant to 5 Physicians and 2 research laboratories. Created and processed confidential correspondence, memos, and excel spreadsheets. Assisted with budget logistics for 3 Research Grants under the Malignant Hematology Program. Purchaser for grant funds and laboratory (PeopleSoft). Managed Physician’s business and personal leave, account benefits and expenses. Renewal of all Physicians licenses and CME credits. Payroll and personal leave coordinator for laboratory personnel. PricewaterhouseCoopers, LLC. Tampa, Florida 11/1995 – 08/1999 Executive Assistant

Executive Assistant to the Defined Contribution Group (GHRS). Editing Proposals, RFP’s, Creating Cover Letters, 401K Monthly Retirement Reports, Created Presentations, Correspondence, E-mails and Budgeting Spreadsheets. Maintained Staff Calendars and Corporate Travel Arrangements. Proofreader for GHRS Group.

COMPUTER/OFFICE SKILLS

NetSuite, Microsoft Office, Access, Quickbooks, Outlook, Excel, PowerPoint, Lotus Notes, PeopleSoft, GEMS, Power chart, EPIC, Right Fax, Internet, NEIS, Amni-Pro, Rainbow, VISIO, EchoSign Software, COMET, TrackWise

CERTIFICATIONS

ASQ Member

ISO9001:2008 Certified Lead Auditor, ISO 9001:2008 CA/PA Certification, ASQ

PQCI, Food Safety Preventive Control

SQF Practitioner

Certified Quality Improvement Associate, ASQ LEASQ, Lean Essentials, ASQ

Gemba, 5S, Value Stream Mapping, Problem Solving using A3, Kaizen, Lean Principles EDUCATIONAL EXPERIENCE

HCC, Tampa, FL – Associates in Business

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