Project Manager Engineer
Resume:
ELBA BELLO
Phone: 954-***-**** Belle Mead, New Jersey 08502 *******@*****.***
QUALIFICATIONS SUMMARY
Results-oriented leader with career success in building and motivating high performing teams. Proven ability
to consistently lead project teams within an intensely regulated industry. Known for enthusiastic leadership
style and “Best in Class” processes. Core competencies include:
Strong Managerial and Organizational Skills Excellent Communication and Presentation Skills
Comprehensive Ability to Create and Implement Process Excellence Trained
Training Protocols Customer Centric; Strategic Thinker
Focus on Continuous Process Improvement and
Outstanding Problem Resolution Skills
Quality Management
PROFESSIONAL EXPERIENCE
JOHNSON AND JOHNSON CONSUMER PRODUCTS, Skillman, NJ 2009 - Present
Project Manager- Quality Engineer, Complaint Vigilance
Responsible for the overview and direct support of consumer complaints while maintaining compliance to
Food & Drug Administration
Ensured FDA Quality System Regulation (21 CFR part 820) and cGMP Compliance.
Performed technical investigation, evaluation and closure of Rogaine Complaints
Ensured complaint trends are monitored, analyzed and reported to management
Communicated with External Manufactures on Batch Record Reviews, retain sample testing
Utilized the DMAIC process to identify root causes on CAPAs
Accomplishments
Identified the need to create CAPAs based on trend analysis
Created a Training Guide for Complaint processing
Partnered with Quality Engineer s to improve Complaint Processing time and documentation practices
2007 – 2008
CAREMARK PHARMACY, Miramar, FL
Operations Supervisor-Dispensing (Non-retail)
Oversaw 35 pharmacy technicians in mail order pharmacy facility to ensure quality and productivity
standards for accuracy and timeliness of order processing
Monitored and coached employees on quality, productivity, and overall work performance.
Formulated operational budget through resource allocation and cost containment strategies.
Partnered with HR to develop and revise employee policies.
Analyzed and presented metrics at daily operations meeting.
Accomplishments
Eliminated product waste by 93% through implementation of inventory controls.
Improved order processing system by creating training progra m, identifying process improvements,
and implementing corrections.
Created rewards and recognition program to increase morale and production levels.
Project Leader for Preventive Maintenance program- successfully eliminating potential for downtime.
2004 – 2006
CORDIS CORPORATION (a Johnson & Johnson Company), Miami Lakes, FL
WW Supervisor, Product Quality Services and Safety Surveillance
Managed 44 highly-diverse employees charged with investigating and processing Cordis Neurovascular,
Endovascular, and Cardiovascular complaints, while maintaining compliance to Food & Drug Administration
(FDA), European Union Medical Device Directives (MDD), governing adverse event reporting.
Ensured FDA Quality System Regulation (21 CFR part 820) and cGMP Compliance.
Designed and monitored departmental call center to ensure prompt and accurate complaint entry for
approximately 30,000 complaints yearly.
Organized and led weekly virtual meetings with clinical research partners in Japan and the Netherlands.
Analyzed and presented audit preparedness FDA reports at management review meetings
Led Project Teams to create SOPs and departmental training program.
Created SAE electronic reconciliation process (eRoom) for clinical research/trials
Developed rewards and recognition program to improve employee morale, goal-setting, and performance.
Spearheaded succession planning and career development; formulated employee evaluations/merit
increases.
Accomplishments
Achieved 30% process documentation improvement by instituting department al best practices.
Successfully improved complaint distribution process flow by 68% utilizing Kaizen event
Established cross-functional relationships with CRO departments to ensure reporting compliance
Significantly reduced audit observations by developin g monitoring procedures, initiating CAPAs and
enforcing Good Manufacturing Practice (GMP)
1999 –2004
NEIGHBORHOOD HEALTH PARTNERSHIP (NHP), Miami, FL
Associate Manager, Provider Operations
Supervised 19 employees in Provider Database Management, PR Call C enter, and Provider Relations
Department
Responsible for database administrators to ensure accurate data entry, data collection and report analysis
Served as Project Leader for Website and Electronic Data Interchange (EDI) Development and Deployment.
Developed metrics and SOPs to measure and improve productivity levels.
Led Data Collection taskforce for Heidis, physician profiling, and HIPPA roll out.
Redesigned and maintained NHP Provider Handbook to educate providers on plan policies.
Designed audit comp liance process to ensure data integrity and prevent fraudulent activity
Accomplishments
Designed quality controls in all department areas resulting in a 96 % improved batch processing system
Created departmental system training program and manual utilized across the organization.
Created PR Call Center to handle claim resolution and contractual disputes
EDUCATION
Bachelor of Science in Management and Leadership, CAPELLA UNIVERSITY, Minneapolis, MN 2007
Associate of Arts in Medical Studies, MIAMI DADE COMMUNITY COLLEGE, Miami, FL 2004
TRAINING / CERTIFICATION
CORDIS CORPORATION (a Johnson & Johnson Company), Miami Lakes, FL
2006
Lean Champion Training Green Belt Training
Concepts for Planning and Prioritizing Building a Winning Team
2005
Train the Trainer Certification Change Management Orientation
Conducting Performance Appraisals
2004
Manager and the Law
Computer Proficiency
Excel Word Outlook PowerPoint Amisys PQMS Seibel
PROFESSIONAL AFFILIATION / AWARDS
WLI (WOMEN LEADERSHIP INITIATIVE - J&J AFFINITY GROUP), Member, 2005
SOUTH FLORIDA HOLA, Chapter Member, 2005
Johnson & Johnson Standards of Leadership Award - Compliance, 2005
Team Excellence Award, 2004
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