Quality Assurance Regulatory Affairs

Michele A. Gonzales

Email: *******.*.********@*****.*** * Mobile: 269-***-***** Kalamazoo, MI, 49001 Highlights of Qualifications

Proficient Computer Regulatory Affairs Legal Document Accounting / Release Hardware/Software Quality Assurance Government Submission Account Management

• EDI Setup / Analysis / Monitor • Pharmaceutical / Medical Device

• Compliance US & INT’L

o All Standards & Regulations

• Quality Management Systems

• SOP Template Creation,

Update, Approval

• Change Control

• Document Change Order

• Engineering Changes

• Archival- Electronic/Hardcopy

• R&D Database Creation

• Training Facilitator

• FDA, USDA, CVM ESub

• US Application/Reg.

• Protocol Submission

• Patent/Trademark

• USPTO Filing & Intl

• CFR 820 Title 21

• ISO 13485 2016

• City, Local, US Legal

• Copyright / Publication

o Search-Reference, TM, Pat.

• Release Accounting/ OEM

• Account EDI Maintenance

• AP/AR-Issue Debit/Credit

• Financial Coordinator

o Contract Request/Review/Entry

• PO Review/Reconcile Entry

o Tooling Blanket, Spot Buy

• Order Forecast/Entry

• New Business Award

• Customer Service

o Investigate / Engineer Confirm

• Manage Calendar Meeting

o Radley / AS400 / Oracle /X12

• SAP CMMS Analytics & Entry

• SAP Work Order/ Schedule

o Engineer Maintenance/Equip

Change Entry, Plan/Report

• Excel, PowerPoint – Ofc 356

• PowerBI, Windchill, LMS

• Adobe Pro / Aerial / Publisher

• Facilitate Training & Migration

o Internal/External Customer

• Create, Maintain DB Matrix

o Piece Price Cost Tracker, Tooling

Employment History

Sr. Project Management - Coordinator Amgen - Agreeya Facilities & Engineering – BioTech Industry (Remote) North Caroliina 01/2024 – Current

Procure, create, maintain various financial, resource management and logistics Reports for Leadership Teams.

Audit support.

Process, track and report Corporate, Financial and Leadership Purchase Order Requests.

Collaborate with Subject Matter Experts (SMEs), Process Owners, Corporate +, to create, process SOP for finalization Electronic Routing ESignatures and implantation in VeevaVault, utilizing various Programs including SmartSheet, CDOCS and more.

Create, maintain and coordinate logistics for On-site and Off-site Warehouse Delivery implementation.

Utilize, create, train various Software - Microsoft 365-Excel (Pivot Tables), PowerPoint, Co-Pilot, Visio BSM360 +

Support, create approval and management of record retention, cross reference compliance and IQA agreements and databases.

Track, manage, schedule, facilitate meetings, training & follow-up MDR, CORP Non-CIDT QMS team procedures and processes.

Develop training programs in LMS. Review / Report annual training for Leadership Team support. Regulatory Affairs - Coordinator Stryker

Quality Management System – Medical Device (The Judge Group) Kalamazoo, MI 02/2023 – 09/2023

Finalize, launch, track Medical Device Standard Operating Procedures (SOP) Document Change Orders (DCO) through complete lifecycle.

Collaborate with Subject Matter Experts (SMEs), Process Owners, Corporate +, to process SOP from document change request, annual reviews, CAPA, NC CAPA, Corporate requests. Support Regulatory Affairs Quality Assurance day-to-day operations.

Analyze MDR, SOP, Work Instruction, Forms, Tables SOP for accuracy, content thoroughness and compliance. Edit, update, finalize and launch for Electronic Review Approval Routing to ensure ISO 13485, 21 CFR 820, EU MDR compliant+, effective and training implemented. Review, analyze, issue, monitor GAP Assessments. Determine deadlines and schedule meetings necessary.

Monitor Corporate Document Control to communicate upcoming division/site changes to SMEs and Process Owners

Utilize, create, train various Software - Microsoft 365-Excel (Pivot Tables), PowerPoint, PowerBi, MasterControl, Trackwise, and OnePLM.

Support, create approval and management of record retention, cross reference compliance and IQA agreements and databases.

Track, manage, schedule, facilitate meetings, training & follow-up MDR, CORP Non-CIDT QMS team procedures and processes.

Regulatory Affairs - Clinical Project Associate Zoetis R&D Veterinary Medicine / Animal Health Kalamazoo, MI 04/2020 – 02/2023

Facilitate and support all levels of Drug/Device Clinical Study Team - directors, scientists, investigators, monitors, and managers.

Determine, create, track, update, analyze and submit schedules, filings necessary for Study Compliance, Application Submission.

Prepare, analyze, edit, facilitate, finalize and submit R&D Regulatory Affairs ESubmission US & International Government Agencies including FDA, USDA, CVB, CVM, MDR for Approval. Copyright Search and retrieval reference. Record, track and report data.

Create, file, monitor, track and submit all study documents including Protocol, Amendment, Deviation, Response, Report, Data Capture Form and any Study Material needed for Regulatory Affairs compliance and submission approval.

Accurately maintain, track, schedule study data metrics utilizing Sharepoint, Excel, VeevaVault +. Electronic/hardcopy file & archival.

Document Control, data and document management. Submit controlled documents and templates to assist with authoring and implementation of documents and reviewing tools, VMRD Best Practices and SOPs. Facilitate, meet and train software, matrix, tools. Michele A. Gonzales

Email: *******.*.********@*****.*** * Mobile: 269-***-***** Kalamazoo, MI, 49001 Employment History

Engineering Enabler Pfizer

Scheduler -Pharmaceutical Engineering Maintenance (HKA / Pfizer 02/2018–02/2019 Kalamazoo, MI) 02/2018 – 04/2020

Analyze SAP CMMS ERP to accurately schedule, organize, delegate and track Engineering Emergency and Preventative Maintenance and Operations industry Work Orders for compliance. Analyze, meet, schedule data daily/monthly/annual for Engineering/Maint teams to determine corrective/predictive Work Order schedules, labor resources and Parts/Tools Order for Craftsmen and teams.

Utilize software including Excel, EAMS SAP, SharePoint, Business Objects, QTS, Microsoft Office Suite, Excel to create, update, record Metric reports for Reliability Engineering Dept. Assign, adjust schedules due to work/tools/labor resources availability to minimize equipment, labor resource downtime. Manage, order Internal/External Orders, Pick Tickets- receive in parts/tools, log, distribute.

Facilitate, create and provide training/materials SAP, DB Matrix creation. Strong attention to detail, critical analytical thinking. Global Account Contract Manager WDP/ Engineered Plastic Services Business Operations / Automotive Plastics Supplier Mattawan, MI 03/2015 – 02/2018

Provide Customer Account Management. Interface with internal / external customers, multiple departments and levels of management including Accounting, engineering, operations, legal and logistics for intl account and contract, order set-up.

Receive, analyze, research and reconcile issues regarding Contracts and Orders to provide high level customer support.

Supply/PO Contract analyst. Coordinate to provide quality, technical and new business support through EDI technical /cust support.

Responsible for EDI system support. Receive, review, analyze and schedule product supply via Electronic Data Interface (EDI), Release Accounting utilizing ERP/Radley Software. Determine, facilitate, forecast, troubleshoot supply/issues. Coordinate internally and externally between production, quality, accounting, supply teams and customer to fulfil orders efficiently as required. Document Control. Create, maintain, update and implement various Access/Excel Tables, Macros and Reports for proper scheduling.

Facilitate and create Trainings/ materials- EDI, ERP, Excel and various OEM including Ford, Software Management. Financial Coordinator / Engineering Administrative Assistant Summit Polymers, Inc Accounting / Automotive Engineering Tech Center Kalamazoo, MI 06/2012 – 03/2015

Coordinate with Engineering, Accounting, Sales, Estimating, manufacturing facilities and Customers - receive, analyze, facilitate, schedule and implement proper authorization for various Engineering Changes, Document Control, Contracts and all documentation, contracts necessary for New Business Awards, accuracy, pricing, effective dates, FOB point and more.

Analyze, determine, reconcile pricing issues, adjustments, discrepancies, credits and debits via Cost Tracker meetings/report maintain.

Piece Price and Tooling Purchase Orders, New Business Awards and Accounting/Engineering reports. Document Control.

Accounts Receivable, Accounts Payable. Excel, Access and SharePoint. Schedule and facilitate Accounting, Engineering, and Cost Tracker meetings. Create, maintain and train Access, Excel- macros, pivot tables, charts and database queries. Schedule, Set-up, Analyze, maintain and update ERP, EDI Release Accounting, AS 400 and various other Ford and OEM Interface/ Software Systems.

Facilitate and create Internal/external Trainings/ materials for various Software customer accounts, including EDI and Excel. Regulatory Affairs Library Technician / Administrative Assistant Pfizer Animal Health Research & Devolpment (Manpower) Kalamazoo, MI 09/2010 – 06/2012

Receive, analyze, research, prepare, update, edit, draft and file Regulatory Affairs R&D legal government applications, publications, submissions, correspondence, reports, studies to the FDA, USDA, CVM, CMC. File Publications

Electronically utilizing Adobe/Publishing via FDA Electronic Submission Tool website. Hard Copies also required and filed.

Create and facilitate training and materials/reports utilizing SharePoint, Excel, Access, Library Document Retrieval.

Software, hardcopy and computer technical support and Document Management.

Proof, edit and create Pharmaceutical Packaging/Labeling - Regulatory Affairs. Legal Secretary / Front Office Flynn, Thiel, Boutell and Tanis, P.C. Patent and Trademark / Intellectual Property Law Firm Kalamazoo, MI 06/2004 – 08/2006

Create, proof, file intellectual property submissions including Medical Device Patents & Trademarks with USPTO and Internationally.

Strong attention to detail required. Strict deadlines and Docket Dates adhered to, domestic and International with the United States Patent and Trademark Office and International Government agencies.

Monitor, track, update filings, documents, calendars, schedules according to all standards and regulations. Conduct Intellectual Property Searches including Copyright. Critical analysis. Document and Database Management.

Facilitate, implement, train and migrate new Software, WorlDocs. Create, edit, update and run Word/Excel Macros and reports.

Front office reception. Manage attorney general email, calendar, schedule meetings, conference rms, transcription, dictation. Education

2

Professional Development Training Certificate Kalamazoo Valley Community College, MI 2009 Computer A+ Software Program Courses Kalamazoo Valley Community College, MI 2008

(Course work complete)

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