Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Languages
Timeline
Generic

DENISTOR CARDONA MERCADO

San Sebastián

Summary

Experienced professional with over 26 years in hi-tech industries, specializing in manufacturing processes and learning and development. Skilled in improving and implementing training programs and methodologies. Responsibilities include overseeing new product launches, establishing manufacturing areas, and ensuring compliance with regulatory requirements.

Overview

27
27
years of professional experience
1
1
Certification

Work History

Sr. Manager, Process Shift Leader, Inspection & Packaging

Bristol Myer Squibb Holdings Pharma Ltd.
01.2007 - Current
  • Performed Project Management Training to all project Leaders
  • Assessed People Related Quality Events to assign Root Cause
  • Analyzed Quality Events Recurrences to correct Human Errors and implemented Preventive Actions
  • Supervised Coop-students
  • Performed Train the Trainer sessions to all functional areas
  • Contributed in process improvement tools such as PM Office
  • Performed Learning Gap Analyses by functional areas to establish the correct knowledge transfer tools.
  • Analyzed changes in training curriculums
  • Created/modified/entered items in Learning Management System
  • Prepared/updated and/or approved curriculums
  • Prepared/ revised and trained personnel
  • Created qualification process for operators.
  • Assessed SOPs to assure instructions are well constructed.
  • Created training Modules for Manufacturing and Supporting areas
  • Evaluated & Contracted External Resources for Specialized Trainings
  • Implemented qualification program.
  • Prepared, Revise and Train in Materials for the Basic Skills Training Workshop
  • Qualified personnel on operational process.
  • Trained staff in General Policies, WBT, GMPs, and Operational Process
  • Special Assignments:
  • Manufacturing Supervisor
  • Kaizen Leader
  • Project Manager

Parenteral Inspection and Packaging , Sr Superviso

Bristol Myers Squib
06.2012 - 03.2021
  • Fostered effective communication by providing constructive feedback and sharing knowledge across business lines.
  • Recruited, hired and trained staff and provided ongoing feedback and performance evaluations for development.
  • Resolved conflicts proactively by facilitating open communication among team members and actively addressing underlying issues.
  • Enhanced team productivity by implementing efficient workflow processes and providing consistent guidance.
  • Provided feedback, training and skill development to staff to improve accuracy, productivity and quality.
  • Implemented cost-saving initiatives, reducing operational expenses without compromising quality or productivity.
  • Maximized personal competency through continuous professional development.
  • Ensured timely completion of projects through effective scheduling and prioritization of tasks based on urgency and importance.
  • Provided interpretation and guidance on procedural questions.
  • Analyzed metrics to identify areas of opportunity, drive performance improvements and consistently exceed operational goals.
  • Mentored junior team members for accelerated professional growth and skill development.
  • Evaluated performance metrics regularly, identifying areas for improvement and providing constructive feedback to employees.
  • Mandated policy, procedure, and performance adherence for continued and increased operational efficiency and profitability.
  • Assessed problems and conflicts and resolved independently.
  • Identified underperforming areas and implemented effective process improvements.
  • Trained new hires and provided positive reinforcement and helpful feedback that boosted morale and efficiency within department.
  • Assumed responsibility and oversight for hiring, onboarding and mentoring new staff members.
  • Reduced employee turnover rates by fostering a positive work environment and addressing staff concerns promptly.
  • Streamlined operations for improved efficiency, delegating tasks and setting clear performance expectations.
  • Conducted thorough quality assurance checks, maintaining high standards of output across all deliverables.
  • Spearheaded efforts to increase cross-departmental collaboration which led to a marked improvement in overall organizational synergy.
  • Championed process improvements in response to identified inefficiencies, resulting in enhanced organizational effectiveness.
  • Developed strategic plans in alignment with company goals, effectively communicating objectives to the team.
  • Fostered a culture of continuous learning, offering ample opportunities for skill enhancement and professional growth to team members.
  • Evaluated employee performance and conveyed constructive feedback to improve skills.
  • Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
  • Successfully managed budgets and allocated resources to maximize productivity and profitability.
  • Streamlined and monitored quality programs to alleviate overdue compliance activities.
  • Leveraged data and analytics to make informed decisions and drive business improvements.

Technical Training Specialist

Bristol Myers Squibb
08.2007 - 06.2012
  • Implemented e-learning platforms to expand access to technical education resources for remote employees.
  • Maintained compliance with industry standards by staying informed about changes in policies or regulations affecting the workplace environment.
  • Collaborated with subject matter experts to ensure accurate, up-to-date content in all training materials.
  • Supported long-term career growth within the organization by developing succession plans that prioritized internal talent development.
  • Promoted a culture of continuous learning by hosting regular seminars, webinars, and workshops on emerging industry trends.
  • Increased overall job satisfaction by fostering a supportive learning environment and addressing employee concerns related to technical skills development.
  • Spearheaded cross-functional collaboration between departments to align technical competencies across the organization.
  • Enhanced company productivity by identifying skill gaps and customizing training materials to address them.
  • Boosted team efficiency with customized group training sessions tailored to specific departmental needs.
  • Evaluated employee performance post-training to measure the effectiveness of instructional methods and materials.
  • Provided coaching and mentoring to employees.
  • Established and maintained quality control standards.
  • Conducted needs assessments to identify gaps in performance and develop targeted learning solutions.
  • Analyzed and evaluated training effectiveness and program outcomes.
  • Developed job-specific competencies and performance standards.
  • Utilized variety of instructional design methodologies to create effective learning experiences.

Sr. Associate Training and Development

Amgen Manufacturing Ltd
01.2006 - 01.2007
  • Supported Internal and External audit acting as Area SME
  • Acted as lead investigator for Area related quality events.
  • Implemented Serialization process.
  • Implemented Kaizen and Yellow Belt Projects
  • Coordinated production schedule.
  • Created schedules based on business needs.
  • Generated CAPA and incident reports.
  • Accountable for manufacturing activities in the Inspection, Packaging, Parenteral Syringes and Parenteral Vials manufacturing Areas.
  • Assured adherence to schedule
  • Supervised Inspection and Packaging Managers
  • Supervised shop floor activities
  • Supervised, documentation, uniforms/gowning, operators, operators’ mechanics, and personnel performing environmental monitoring Coordinate Mechanical Activities and coordinate Preventives and Correctives maintenance.
  • Revised Approve and/or update SOP’s, Work Instructions, Batch Records to comply with current practices
  • Supported Operational Excellence activities by identifying areas of improvement or by leading these initiatives
  • Performed investigations related to non-conformances or quality events and assign a root cause.
  • Contacted external suppliers for requesting their services.
  • Performed internal audits to assure area compliance
  • Performed Inventory adjustments in SAP
  • Initiated vendor feedback on or complaints to suppliers
  • Verified attendance at Kronos System.
  • Created schedules based on business needs.
  • Improved areas and processes to comply with regulatory agencies.
  • Lead Quality Standard Implementation for incoming materials.
  • Managed Projects for Engineering, Manufacturing & Micro Labs
  • Lead Operational excellence team to improve processes utilizing DMAIC methodology
  • Completed OJT General Modules for Manufacturing.
  • Implemented serialization process in packaging lines.
  • No major observations during several internal, external, government and federal regulatory audits in my matters of expertise.

Trainer

Pfizer
01.1998 - 01.2006
  • Led project initiatives to comply with Gowning regulations.

  • Mentored new hires, resulting in stronger staff development and increased productivity.
  • Evaluated the effectiveness of training initiatives by tracking participant progress and gathering feedback for continuous improvement.
  • Coached employees on best practices, providing constructive feedback to support their professional growth.
  • Provided one-on-one mentoring to help individuals reach their full potential within the organization.
  • Collaborated with subject matter experts to create accurate training content.
  • Enhanced trainee engagement through interactive workshops and hands-on activities.
  • Delivered dynamic presentations to facilitate learning and retention among diverse audiences.
  • Streamlined processes for creating, updating, and distributing training materials, resulting in significant time savings for staff members involved in these tasks.
  • Conducted comprehensive needs assessments to identify gaps in knowledge and skills, informing future program development.
  • Developed customized training materials for various industries, ensuring relevance to the target audience.
  • Optimized training delivery schedules, accommodating diverse learning styles and work commitments.
  • Led cross-functional team to update training curricula, keeping pace with industry changes.
  • Facilitated virtual, in-person and blended learning sessions.
  • Established and maintained quality control standards.
  • Conducted needs assessments to identify gaps in performance and develop targeted learning solutions.
  • Developed job-specific competencies and performance standards.
  • Lead Gowning and Sanitation team in day to day tasks
  • Scheduled daily activities prioritizing business need.

Education

MBA - Management and Strategic Leadership

Sistema Universitario Ana G. Mendez
Barceloneta, P.R.

Business Administration And Management

Sistema Universitario Ana G Mendez
Barceloneta
06.2006

Skills

  • Process Mapping
  • Design of Experiment
  • Investigation & Root Cause Analyses
  • Process Improvement
  • Serialization
  • Medical Device
  • Aseptic Processing
  • Biological Manufacturing
  • Validation
  • New Processes Implementation
  • New Products Integration

Certification

  • CAPA System Expert Certification
  • Combined Product
  • Basic Microbiology
  • Biotechnology Training
  • BMS Kaizen Leader
  • Instructional Designer / Developer Certification
  • Project Management Fundamental
  • CGMP for Combination Products for Trainers
  • Talsico Human Error Reduction
  • KT Problem Solving and Decision Making
  • Writing Effective Procedures
  • Risk Review Leadership
  • Advance PowerPoint
  • Human Resource Development
  • How to structure and teach SOP’s
  • Advance Strategies of Oral Presentation
  • Internal System Auditor
  • Planning, coordination and development of training program
  • The Human Resource and the Quality in Organizations
  • Job skills/Lesson Plan Design
  • Improving Investigation & Preventing Human Error
  • C’GMP for Trainers

Accomplishments

  • Increased OEE% and sustained in Packaging lines
  • Reduced equipment setup time activities in 59%
  • Implemented Manufacturing Skill Qualification Program

Languages

Spanish
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)

Timeline

Parenteral Inspection and Packaging , Sr Superviso

Bristol Myers Squib
06.2012 - 03.2021

Technical Training Specialist

Bristol Myers Squibb
08.2007 - 06.2012

Sr. Manager, Process Shift Leader, Inspection & Packaging

Bristol Myer Squibb Holdings Pharma Ltd.
01.2007 - Current

Sr. Associate Training and Development

Amgen Manufacturing Ltd
01.2006 - 01.2007

Trainer

Pfizer
01.1998 - 01.2006

MBA - Management and Strategic Leadership

Sistema Universitario Ana G. Mendez

Business Administration And Management

Sistema Universitario Ana G Mendez

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