Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Languages
Timeline
Generic
MAGDALIS FIGUEROA-ALVAREZ

MAGDALIS FIGUEROA-ALVAREZ

Deltona

Summary

An Industrial Engineer professional with vast experience and a straightforward approach mindset toward leadership, strategic planning, change management, change control, project management, and continuous improvement in the pharmaceutical, medical devices, information technology, and service industry for private and government-owned corporations using Lean Enterprise methodology. Has a solid track record in taking ownership of relevant projects and a leading role in key programs; completing projects, and initiatives to improve customer satisfaction, site performance, productivity; safety; compliance, and delivering high-impact results with significant time savings, productivity, performance, and cost-efficiency. An accountable and self-starter professional always striving for excellence and innovation. Possesses management experience, including coaching and leading teams in multicultural environments, conflict resolution, root cause problem solving, change management, and statistical data analysis. Displays excellent communication skills in English, Spanish, and Papiamento. Project Manager versed in all aspects of project and personnel management. Results-oriented and high-energy professional with talent for leading by example and inspiring peak performance. Dedicated to fostering strong effective team relationships.

Overview

1
1
Certification

Work History

Value Chain Management/Product Delisting Project Manager

Johnson & Johnson – Contractor for Brooksource, LLC
- Current
  • Scope, planned, executed and transitioned various assigned projects within the Value Chain Management organization of Product Management within the Janssen Supply Group.

Site Commercialization Project Manager – Supply Chain Operations

AMGEN, JUNCOS PR – CONTRACTOR FOR EB VALIDATION
  • Developed, implemented, and supported labeling and CMC regulatory strategies and processes to ensure timely and compliant Amgen pharmaceutical, medical devices, and combination products, global launches executions, worldwide variations implementations (FDA/EMEA/PMDA/TGA/ICH/MHRA/NMPA/EU MDR), and any other regulatory activities related to the product life cycle management using Trackwise, the change control management system from End-to-End following the applicable regulations and business standards.

Supply Chain Project Manager

AMGEN, JUNCOS PR – CONTRACTOR FOR EB VALIDATION
  • Led change control projects for new external warehouses and Information Technology (IT) SAP/ERP system enhancements.

Education

Master of Science - Manufacturing Engineering

Polytechnic University of Puerto Rico
San Juan, PR
06.2015

Bachelor of Science - Industrial Engineering

Polytechnic University of Puerto Rico
San Juan, PR
06.2000

Skills

  • English
  • Spanish
  • Papiamento
  • MS Office (Word, Excel, PowerPoint)
  • MS Project
  • MS Visio
  • Peachtree Accounting
  • QuickBooks
  • Trackwise
  • Veeva Vault
  • CDOCS
  • Sharepoint
  • SmartSheet
  • SAP ERP
  • Continuous Improvement
  • Lean Six Sigma
  • Leadership Coaching
  • Facilitation & Coaching
  • Problem Solving Methodologies
  • Business Analytics
  • Technical Writing/SOPs
  • Process Improvement
  • Quality Management
  • Kaizen Methods
  • Project Management
  • Data Analytics
  • Strategic Planning
  • Quality Systems
  • Teaching and Training
  • Master Data/BOM’s
  • Change Control Management
  • Value Stream Mapping
  • Business Metrics
  • Results Presentation
  • Operational Planning
  • Work flow planning
  • Productivity Improvement
  • Project development
  • Logistics Management
  • Resource Allocation
  • Risk Management
  • Vendor Sourcing
  • Workforce training
  • Technical Support
  • Data Analysis
  • Schedule Management
  • Project tracking
  • Project Planning
  • Document Management
  • Inventory Control
  • Compliance Monitoring
  • Procedure Development
  • Cost Control
  • Contract Management
  • Root Cause Analysis
  • Staff training and motivation
  • Software Development Lifecycle
  • Microsoft Office Suite expert
  • Purchasing and procurement
  • Conflict Management
  • Quality assurance and control
  • Stakeholder Communications
  • Presentations
  • Baseline schedules creation
  • Performance Improvements
  • Budget Administration
  • Contract Development
  • Requirements Gathering
  • Processes and procedures
  • Project scope analysis
  • Project scope
  • Data review
  • Mergers and acquisitions knowledge
  • Client rapport
  • Multi-unit operations management
  • Business process re-engineering
  • Budgeting and forecasting
  • Staff Management
  • Business Analysis
  • Budget Control
  • Project development and lifecycle
  • Project Scheduling
  • Coaching and Mentoring
  • Meeting facilitation
  • Staff training and mentoring
  • Lean manufacturing and design
  • Scope Management
  • Project feedback data
  • Cost reduction and containment

Certification

  • PROJECT MANAGEMENT PROFESSIONAL (PMP), 3151180, 10/2021 - Present, Project Management Institute (PMI), Newtown Square, PA
  • Lean Six Sigma Green Belt Healthcare, In-Progress, Six Sigma Global Institute, Boston, MA
  • Leadership Coaching Certification, August - December 2018, CoachArt Institute, San Juan, PR
  • Lean Six Sigma Green Belt Certification, 06/2016, Polytechnic University of Puerto Rico (PUPR), San Juan, PR
  • Certified Quality Engineer (CQE), 61266, 06/2013 - Present, American Society for Quality (ASQ), Milwaukee, WI

Accomplishments

  • Led a major project to correct data quality errors in a governmental healthcare database. More than 1.5 million data quality errors were corrected using available human resources and tools.
  • Successfully streamlined business metrics process from 12 hours to 4 hours.
  • Presented analysis, metrics, and results. Identified underperforming products in the business using business and data analytics.
  • Developed and implemented the strategy, the documentation, and the Lean Six Sigma required methodology to manage over 2,000 claims work overload due to the Maria Hurricane catastrophic event. Created a stratified status system for open claims; identified and eliminated duplicated data to speed up the customer’s claim and settlement processes.
  • Standardized and systematized reports for the data acquisition process which saved 75% in time from 24 to six hours.
  • Coached Engineers and Project Managers to identify cost-reduction opportunities to develop individual annual review projects.
  • Led major warehouse operations change management project for a pharmaceutical company.
  • Contributed to the development of the Lean Continuous Improvement program in a major pharma manufacturing plant. Identified major quality and performance issues and suggested corrective actions.
  • Investigated data quality problems, conducted root-cause analysis, corrected errors, and developed process improvement plans across all programs.
  • Trained personnel on new process initiatives, Lean Six Sigma methodology, and leadership skills. Collaborated in the development and communication of the Lean group’s philosophy, vision, and expectations.
  • Led Kaizen events and brainstorming sessions applying Lean Manufacturing and Lean Six Sigma Tools and principles.
  • Established external warehouse operations to increase inventory levels to comply with the Covid-19 contingency plan.
  • Developed strategies for process improvement like department cross-functionality assessments, available technology use, functions and duties training and retraining, workstation redesign, ergonomics, time management, process standardization, flowcharts, process mappings, value stream mapping, and standard operating procedures.
  • Led a national pilot project; provided strategic direction for the optimal implementation within a $500K budget. Responsible for the project planning, development, logistics, and execution to reach 25 schools and 2000 children in Curacao. Conducted financial analysis and forecasts.
  • Played a key role in the Technical Services Department achieving 95% updated workload in six months and increased the Documentation Department documentation annual review process effectiveness from 5% to 90% in one month.
  • Led continuous improvement initiatives in the weighing and dispensing and coating process areas to improve and standardize plan values. Overall project improvement ranged to $8.2M cost reduction.
  • Implemented an audit program to set under control an administrative process and recovered $6M out of $8M in account receivables.
  • Led field clinical trials for a cardiovascular medical device intended to substitute a traditional medical procedure.
  • Developed the complete documentation quality system to comply with 21 CFR Part 111 – Dietary Supplements for a major US manufacturer and distributor. Additionally, provided SOP training to upper management and end-users.
  • Developed and reviewed SOPs applying Howard Gardner’s Multiple Intelligences Theory to reduce quality and performance error in a GMP, FDA-regulated industry based on 21 CFR Part 11, 210/211, and 820 regulations.
  • Led various initiatives related to global product launches from End-to-End and collaborated with the Sales and Marketing department to ensure that the market campaign was fulfilled as planned.
  • As Data Quality Manager supervising a team of ten people some of them remotely; measured and promoted effectiveness per team member to eliminate 100% of system errors; implemented random audits.
  • Corrected over one million data errors systematically and manually using data analysis principles and business metrics.
  • Developed the entire Coca a-Cola Quality System documentation and related programs for the Curaçao site and obtained a 97% passing rate. Performed as the Coca-Cola Quality System Champion for the site.
  • Led the Quality Assurance and Quality Control Units training facilitation, management, administration, and supervision of 10 direct reports teams. Oversaw the work of over 150 employees as Quality Assurance Manager.
  • Facilitated regional training on Data Quality and Good Documentation Practices for nurses and health department service providers.
  • Served as a consultant to the Quality Director, provided data analysis, business metrics, and results, and assisted in upper management presentations and weekly status meetings.
  • Conducted internal and external audits and investigations to improve processes performance and operational quality assurance.
  • Led customer complaints, quality issues, CAPA, and the Material Review Board (MRB) programs and implemented CAPA initiatives resulting from external and internal audits.

Languages

Spanish
First Language
English
Proficient (C2)
C2

Timeline

Value Chain Management/Product Delisting Project Manager

Johnson & Johnson – Contractor for Brooksource, LLC
- Current

Site Commercialization Project Manager – Supply Chain Operations

AMGEN, JUNCOS PR – CONTRACTOR FOR EB VALIDATION

Supply Chain Project Manager

AMGEN, JUNCOS PR – CONTRACTOR FOR EB VALIDATION

Master of Science - Manufacturing Engineering

Polytechnic University of Puerto Rico

Bachelor of Science - Industrial Engineering

Polytechnic University of Puerto Rico
MAGDALIS FIGUEROA-ALVAREZ