Leverage and enhance my skills and knowledge to achieve outstanding results in assigned tasks. Continuously acquire new experiences, knowledge, and skills to contribute to the company’s success both professionally and personally.
Overview
16
16
years of professional experience
Work History
Associate Manufacturing
Amgen Manufacturing Limited
01.2018 - Current
Execute manufacturing tasks following Standard Operating Procedures (SOPs) to ensure consistency and quality.
Regularly review and update SOPs to reflect current practices and improvements.
Oversee and manage essential manufacturing processes to ensure they are running smoothly and efficiently.
Carry out validation protocols to confirm that manufacturing processes meet required standards and specifications.
Adhere to Good Manufacturing Practices (GMPs) to maintain product quality and safety.
Create and update necessary documentation to support manufacturing activities and compliance.
Maintain accurate and thorough records of manufacturing processes and quality checks.
Continuously seek opportunities to enhance manufacturing processes and recommend actionable improvements
Support the review and approval of documentation related to specific manufacturing functions.
Provide guidance and direction to operators during critical manufacturing processes to ensure proper execution.
Determine and manage priorities to ensure efficient workflow and timely completion of tasks.
Present manufacturing data and reports to management for review and decision-making.
Lead initiatives to improve Overall Equipment Effectiveness (OEE) .
Utilize skills and knowledge from Yellow Belt certification to lead and contribute to process improvement projects.
Mentor and train other employees, sharing knowledge and best practices to enhance team performance.
Functional Compliance in the Construction Department
Terumo Medical Corporation (St. Jude)
01.2018 - 03.2019
Oversee quality documentation, including initial and ongoing shift tests, configuration, and material transfers.
Supervise a team of 16 production line members.
Manage equipment rotations.
Receive and handle batches of raw materials.
Calibrate machinery on each production line according to compliance dates.
Reconciliate final production checks and verify "scraps" materials.
Regulate eight stations for medical device production.
Manufacture specialized medical heart devices.
Certificate in operating and managing multiple assembly stations.
Skilled in troubleshooting and maintaining equipment to ensure smooth production flow.
Specialized in the SFP (Standardized Functional Process) methodology.
Expertise in reconciling production batches with corresponding documentation.
Capable of troubleshooting and optimizing drying processes for efficiency and quality.
Supervisor
Sears Holdings, Kmart Corp.
01.2009 - 01.2016
Coordinate with 20-25 team members and assign tasks
In charge of the payment records, the sales floor and the warehouse with an approximate value of $ 1 to $ 1.5 million in inventory
Supervise the best customer service
Manage cash and store sales accounting
Manage federal programs such as Western Union Money Transfer
Manage federal forms such as the Suspicious Activity Report (SAR)
Internal and external relationships with other stores and suppliers
Assistance in operational and technical procedures with registries, cash management, customer service and pharmacy
Undergraduate researcher
University of Puerto Rico at Humacao
01.2014 - 12.2014
Project: Effect of pH on density, activity and microbial diversity
Supervisor: Francisco Fuentes, PhD
Study of soil in Punta Santiago Beach, Humacao PR
Clinical Research Assistant
Veterans Hospital
01.2013 - 12.2014
Project: Insulin resistance and insulin receptor expression in prostate cancer
Processing of patient data in the study
PI: Lourdes Guerrios, MD
Community Volunteer
Hospital HIMA
01.2013 - 12.2013
Assistance in medical process in Pediatric Oncology
Education
Master of Business Administration - Concentration, Quality Management
Ana G. Mendez University
Caguas, PR
05.2020
B.S. - Concentration, Microbiology
University of Puerto Rico at Humacao
Humacao, PR
05.2016
Skills
Technical Skills:
Microbiology: Industrial and Applied
GMP(Good Manufacturing Practices)
SOS(Standard Operating Procedures)
OSHA(Occupational Safety and Health Administration)
ISO(International Organization for Standardization)
SSOP(Sanitation Standard Operating Procedures)
CIP(Clean-in-Place)
SIP(Sterilize-in-Place)
HACCP(Hazard Analysis Critical Control Point)
PCC(Process Control Chart)
QA(Quality Assurance)
FAO(Food and Agriculture Organization)
API TRAM(Active Pharmaceutical Ingredient Traceability and Management)
CAPA(Corrective and Preventive Actions)
Quality Control Management
Six Sigma: DMAIC (Define, Measure, Analyze, Improve, Control)
Statistical & Inferential Analysis
Lean Manufacturing
TQM(Total Quality Management)
Competitive Manufacturing
Software Proficiency:
Microsoft Office: Word, Excel, PowerPoint, Publisher, Outlook
SAP(Systems, Applications, and Products in Data Processing)
EBR(Electronic Batch Records)
TrackWise (Quality Management Software)
Citrix
Smartsheet
Yellow Belt Certification
Interpersonal Skills:
Ability to work fast
Teamwork
Work Independently
Work Under pressure
Problem-solving skills
Ability to present results
Communication
Empathy
Negotiation
Conflict Resolution
Emotional Intelligence
Leadership
Team Collaboration
Adaptability
Reliability
Attention to Detail
References
Available to be necessary
Timeline
Functional Compliance in the Construction Department
Terumo Medical Corporation (St. Jude)
01.2018 - 03.2019
Associate Manufacturing
Amgen Manufacturing Limited
01.2018 - Current
Undergraduate researcher
University of Puerto Rico at Humacao
01.2014 - 12.2014
Clinical Research Assistant
Veterans Hospital
01.2013 - 12.2014
Community Volunteer
Hospital HIMA
01.2013 - 12.2013
Supervisor
Sears Holdings, Kmart Corp.
01.2009 - 01.2016
B.S. - Concentration, Microbiology
University of Puerto Rico at Humacao
Master of Business Administration - Concentration, Quality Management
HRBP, AML Quality and Facilities & Engineering / Org Effectiveness Lead at Amgen Manufacturing LimitedHRBP, AML Quality and Facilities & Engineering / Org Effectiveness Lead at Amgen Manufacturing Limited