Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
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Isis Gonzalez Carmona

Orlando,FL

Summary

Committed Quality Assurance professional with nineteen years background in biotechnology industry with success in manufacturing process and finished drug packaging and quality standards. Highly qualified High School Science Teacher with six years of experience in classroom management in biology, chemistry and physics concepts. Disciplined professional with strong problem-solving, analytical thinking and time management skills. Committed to making meaningful contributions and advancing organizational goals.

Overview

23
23
years of professional experience
1
1
Certification

Work History

Senior Quality Assurance Associate

Amgen Manufacturing Limited
06.2014 - 05.2024
  • Provided quality oversight 50+ production employees to ensure qualifications and products are manufactured, inspected, packaging, stored, and distributed according to current GMP and compliance.
  • Reviewed and approved documentation during and post-execution through data integrity audits related to electronic batch records, records, environmental monitoring and sampling, standard operating procedures, cleaning/sanitization process, corrective actions, change controls and protocols for over 30+ products prior to QA Disposition.
  • Performed Acceptable Quality Limit (AQL) inspections and approved products, components, and labeling to accept or reject the production lot or shipment.
  • Executed detailed inspections protocols for a new product implementation, enhancing product reliability and customer satisfaction ratings by 25%.
  • Collaborated internal/external audits as part of the audit management team, and others departments; as needed.
  • Actively engaged and participated in quality productivity, continuous improvement initiatives and LEAN manufacturing programs.


Senior Manufacturing Associate III

Amgen Manufacturing Limited
02.2005 - 06.2014
  • Worked as a senior manufacturing associate and shift leader for bulk drug product in upstream and downstream area.
  • Executed tasks and operations related with bioreactors, chromatography and filtration skids, buffers/media preparation, UV Spectroscopy, bulk filtration and inclusion body recovery, and production batch record review.
  • Supervised and trained new production staff to ensures manufacturing production schedules are executed and completed.
  • Lead and interacted with the daily production meetings and performed presentation in different levels and forums.
  • Collected, analyzed and stored production samples according to guidelines and regulations.
  • Documented daily production data and submitted accurate time logs to keep management up-to-date, using electronic batch record (EBR) and standardized operations procedure (SOP).
  • Participated in the design and implementation of critical processes and/or facilities, validation protocols and change controls with system and process owners comply with GMP regulations.
  • Provided troubleshooting support of production process operations with evaluate, plan, and implement solutions for process improvement opportunities.
  • Initiated, revised, updated and reviewed standard operational procedures and controlled records using electronic documentation system.

Science Teacher

Colegio San Juan Apóstol Y Evangelista
08.2001 - 01.2005
  • Design the teaching of concepts according to the scope and level of depth as high school science teacher.
  • Plan and develop activities taking into consideration learning styles to address individual differences in science topics, such as biology, chemistry, or physics.
  • Establish reflective communication with fellow teachers, support staff, students, parents or caregivers regarding academic progress, assignments and behavior.
  • Keep replacement material up to date; Maintain up-to-date administrative documentation, delivery of plans, attendance and evaluations as required.
  • Incorporated project-based learning into the curriculum, challenging students to apply scientific principles in real-world situations while developing teamwork skills.
  • Ensure compliance with school policies and regulations.

Education

MBA - Education

Ana G. Mendez University
Gurabo, Puerto Rico
06.2004

Bachelor of Science - Biology

University of Puerto Rico
Mayaguez, Puerto Rico
06.2001

Skills

  • Quality Assurance
  • Manufacturing Operations
  • AQL Sampling
  • EBR, SAP/WERUM, LIMS, TrackWise QMS, Maximo, Infolinx
  • GxP-GMP Knowledge
  • MS Office and Google Workspace
  • Analytical Thinking
  • Attention to Detail
  • Problem-Solving
  • Time Management
  • Classroom Management / Curriculum Development

Certification

  • CQA - Certified Quality Auditor
  • ASQ Member
  • Certified Information Mapping Professional (IMP)
  • Certified Secondary Science Teacher, P.R. Department of Education

Languages

Spanish
English

Timeline

Senior Quality Assurance Associate

Amgen Manufacturing Limited
06.2014 - 05.2024

Senior Manufacturing Associate III

Amgen Manufacturing Limited
02.2005 - 06.2014

Science Teacher

Colegio San Juan Apóstol Y Evangelista
08.2001 - 01.2005

MBA - Education

Ana G. Mendez University

Bachelor of Science - Biology

University of Puerto Rico

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Isis Gonzalez Carmona