Summary
Overview
Work History
Education
Skills
Timeline
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Mara Negron

Mara Negron

Microbiologist
Humacao,Puerto Rico

Summary

Dynamic scientist specialized in major manufacturing sectors, such as the pharmaceutical, quality management, and high tech sectors. Experienced in good manufacturing practices and operational efficiency including quality assurance. Strong collaborating and problem-solving abilities, ensuring production targets are met. Committed to continuous improvement, Iean manufacturing and meticulously document processes to support data-driven decision-making.

Overview

11
11
years of professional experience
2
2
Languages

Work History

IPT Operator

Merck
03.2017 - Current
  • Maintained knowledge of industry policies and procedures to set up and operate equipment safely.
  • Perform AQL inspections for quality standards.
  • Document all operational data using ALCOA principles ensuring up-to-date records for review and analysis.
  • Review and translation of batch records.
  • Collaborate on electronic batch records design and validation.
  • Handled adjustments or modifications to machines as needed based on product specifications or changes in operational parameters.
  • Met production targets and tight deadlines by collaborating closely with team members.
  • Solid dosage compression.
  • Execute tablet coating process and sampling.
  • Product weighing and disposition.
  • Use of NIR equipment to monitor functional coating process.
  • Formulation of active ingredient suspension and color solution.
  • Perform material transactions on SAP for inventory control and material status prior to use.

Manufacturing Associate

Amgen
11.2014 - 03.2017
  • Prepare formulation and filling equipment ensuring timely availability of necessary materials.
  • Perform filter integrity tests to confirm process quality.
  • Autoclave operation and assistance during validation process.
  • Collect water samples for total organic carbon (TOC) analysis.
  • Updated production logs with detailed accuracy, facilitating effective tracking and analysis.
  • Documentation review.
  • Implemented 5S methodology to maintain organized and efficient production area.
  • Use of Manufacturing Execution System (MES) to document manufacturing steps.

Education

Bachelor - Microbiology

University of Puerto Rico
Humacao

Master In Manufacturing Competitiveness - Quality Management

Polytechnic University of Puerto Rico
San Juan
06.2021

Skills

Teamwork and collaboration

Timeline

IPT Operator

Merck
03.2017 - Current

Manufacturing Associate

Amgen
11.2014 - 03.2017

Bachelor - Microbiology

University of Puerto Rico

Master In Manufacturing Competitiveness - Quality Management

Polytechnic University of Puerto Rico

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