Microsoft
Alex Frankovich
Quality Assurance Change Analyst / Labeling Specialist
San Jose,CA
Summary
My interest in Quality Assurance and Labeling started with my interest in Business. I enrolled at the University of Phoenix because of its strong Business program to learn how to interpret business needs, function as an engaged professional, and prepare for my professional career. My background includes strong Quality Management experience skills, especially involving document control and quality process engineering.
Overview
12
12
years of professional experience
2
2
years of post-secondary education
Work History
Labeling Process Lead
Johnson And Johnson Surgical Vision
Irvine , CA
2021.10 - 2022.07
- Organized product-line labeling components and prepared part documentation for EU MDR Change Orders
- Coordinated with Platform RA on necessary EU MDR Changes to labeling graphics and content
- Collaborated with External Manufacturers to deliver released labeling parts for production activities
- Assisted in developing new first article labeling verification process between JJSV and External Manufacturers by creating updated Adobe eForm for electronic signatures
- Developed and gained approval on FDA required symbol glossary for online publication
- Collaborated with cross-functional team to analyze and rewrite QMS documents to align with current business practices
- Conducted research, gathered information from multiple sources and presented results.
- Carried out day-to-day duties accurately and efficiently.
Quality System Change Analyst
Johnson And Johnson Surgical Vision
Irvine , CA
2019.11 - 2021.10
- Reviewed historical documentation to discern trends in operational metrics, informing future decisions on operational changes and potential improvements.
- Participated in high-level change management strategic planning, incorporating input from stakeholders, internal support staff and external factors.
- Proactively developed and proposed changes increasing productivity, compliance and other positive indicator metrics.
- Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
- Used Microsoft Word and other software tools to create SOPs, Forms, and other communications.
- Offered friendly and efficient service to customers, handled challenging situations with ease.
Quality System Change Analyst
Johnson And Johnson MedTech
Irvine , CA
2019.06 - 2019.09
- Organized classification analysis of Medical Device Directive (MDD) referenced themed documents for reassignment and updates as they pertained to the EU Medical Device Regulations (MDR) 2017/745
- Participated on cross-functional team with input and analysis on 5 different PLM systems
- Processed Change Orders within the 5 different PLM systems
Quality Document Specialist
AAE
Huntington Beach , CA
2017.04 - 2019.02
- Prepared digital files, physical documents and work requests in compliance with company guidelines.
- Transmitted documents, organized revisions and tracked changes.
- Proofread filenames, titles and submittal details to streamline submittal and avoid rejection.
- Provided support for document controls and worked with contract documents.
Document Control Specialist
Percussionaire
Sagle , ID
2016.08 - 2016.11
- Executed validation protocol for ultrasonic water bath
- Created user interface forms in Live Cycle Designer
QA Technician
Cygnus
Ponderay , ID
2013.07 - 2014.06
- Performed Geometric Dimension and Tolerancing per work-order
- Performed measurements and executed work-orders for quality assurance
- Assisted team in overall production schedule and work assignments
Document Control Specialist III
Applied Medical
Rancho Santa Margarita , CA
2009.10 - 2012.04
- Designed Computer Printed labels in Label Matrix
- Maintained User Interface Forms in Adobe Live Cycle Designer
- Performed electronic and manual document distribution tasks as they pertain to the document control office
- Trained new employees on all document control software and SAP data management
- Managed all SAP (ERP) documentation for entire product catalogue
- Processed DCRs for SOPs, Labels, and Information for Use Pamphlets (IFU)
- Authored department specific Standard Operating Procedures
Document Control Specialist
Amylin Pharmaceutical
San Diego , CA
2008.09 - 2009.06
- Participated in FDA Pre-Approval Inspection for launch of new drug application to market for multi-million-dollar diabetes product
- Performed electronic and manual document distribution tasks as they pertain to the document control office at a top-ten best places to work company
- Analyzed customer service needs to provide alignment for document processing needs
- Assessed upcoming control points for the distribution of electronic records
- Guided internal clients through daily processes by providing feedback on document status and change control availability
- Maintained logbook inventory
Document Control
Gen-Probe
San Diego , CA
2006.07 - 2007.06
- Given responsibility for all word processing tasks in document control
- Managed and created reports in Crystal Reports
- Resolved customer workflow issues
- Registered electronic documents in EDMS
- Registered workflows for document and engineering change orders
- Launched workflows for change control
- Maintained GMP standards for document storage/ signature needs (procedures, batch records, reports, protocols, raw material and disposable material specifications, drawings, notebooks, and logs)
Document Control Associate
VICAL
San Diego , CA
2005.08 - 2006.01
- Given responsibility for Disposable Material/Raw Material Specification review
- Given responsibility for Change Control Process
- Companywide document issuance process
- Document word processing and formatting
Manufacturing Tech II
IMCOR
San Diego , CA
2004.01 - 2005.07
- Executed standard operating procedures (SOP) following pharmaceutical quality guidelines
- Performed batch production records (BPR) and persuaded appropriate changes
- Performed document change control (C.C.) and document revamp per procedural improvement
- Accessed document archives and utilized documentation per project requirements
Education
Bachelor of Science - Business Management
University of Phoenix
Online 2002.06 - 2004.06
Skills
Change Control
undefinedAffiliations
- American Society for Quality
- Society for Technical Communication
Software
Adobe Professional DC
Agile PLM
SAP
Other PLMs
Timeline
Labeling Process Lead
Johnson And Johnson Surgical Vision
2021.10 - 2022.07
Quality System Change Analyst
Johnson And Johnson Surgical Vision
2019.11 - 2021.10
Quality System Change Analyst
Johnson And Johnson MedTech
2019.06 - 2019.09
Quality Document Specialist
AAE
2017.04 - 2019.02
Document Control Specialist
Percussionaire
2016.08 - 2016.11
QA Technician
Cygnus
2013.07 - 2014.06
Document Control Specialist III
Applied Medical
2009.10 - 2012.04
Document Control Specialist
Amylin Pharmaceutical
2008.09 - 2009.06
Document Control
Gen-Probe
2006.07 - 2007.06
Document Control Associate
VICAL
2005.08 - 2006.01
Manufacturing Tech II
IMCOR
2004.01 - 2005.07
Bachelor of Science - Business Management
University of Phoenix
2002.06 - 2004.06
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