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Mimi Bui Email & Phone Number

Quality Assurance & Control | Process Optimization | Quality Management Systems at Minaris Regenerative Medicine
Location: Mountain View, California, United States 4 work roles 1 school
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Role
Quality Assurance & Control | Process Optimization | Quality Management Systems
Location
Mountain View, California, United States
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Who is Mimi Bui? Overview

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Mimi Bui is listed as Quality Assurance & Control | Process Optimization | Quality Management Systems at Minaris Regenerative Medicine, a company with 150 employees, based in Mountain View, California, United States. AeroLeads shows a matched LinkedIn profile for Mimi Bui.

Mimi Bui previously worked as Associate Director, QC Analytical & Microbiology at Minaris Regenerative Medicine and Senior Manager, Quality Control - Reagent at Rebus Biosystems. Mimi Bui holds Bachelor Of Science In Chemistry, Chemistry from Long Island University.

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Minaris Regenerative Medicine

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About Mimi Bui

Passionate about maintaining the highest quality standards in every aspect of the work, I am a detail-oriented professional with extensive experience in QC and QA. Throughout my career, I have excelled in reviewing and approving test results, supporting seamless product releases, and ensuring the continuous stability testing of various processes.My expertise extends to implementing operational procedures that guarantee regulatory compliance with entities such as FDA, GMP, ICH, ISO, CLIA, and OSHA. I take pride in fostering departmental adherence to established procedures, ensuring a robust foundation for quality assurance.I bring a unique combination of technical expertise, leadership experience, and a proven track record of delivering results. In my previous role at Thermo Fisher Scientific, I not only led a team that always met above 95 % of product deliverables but also implemented process improvements that saved the company 15 - 20 % of inventory scrap. I made the necessary effort to provide support within QC and to collaborate cross-functionally is a key strength, allowing me to address quality challenges effectively and optimize processes for maximum effectiveness.I have over 15 years of experience managing teams of 10 to 15 people. I oversaw the daily operations, laboratory performance, and projects. I was responsible for ensuring timely and accurate delivery. I directed employees to achieve company standards in productivity, quality, and continuous improvement. My leadership philosophy is coaching, delegating, supporting, and providing 2-way feedback that promotes employee development, innovation, and a client-focused mindset. I empowered my employees by setting clear measured goals and expectations, and regularly checking progress to ensure projects stay on track; promoting team building, and recognizing individuals and team achievements.I am skilled in developing and executing communication tools, establishing and tracking Key Performance Indicators (KPIs) for Quality Control, and ensuring audit readiness for regulatory inspections. My commitment to excellence and meticulous attention to detail position me as a valuable asset in any quality-driven environment. Let's connect and explore how my skills and experience can contribute to the success and growth of your organization.COMPETENCIES• QC/QA • Process Optimization • Quality Audits & Testing • Quality Management Systems• Regulatory Compliance• Product Stability Monitoring• Team Building & Leadership• Cross-Functional Collaboration• Continuous Improvement

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Minaris Regenerative Medicine
Minaris Regenerative Medicine
Quality Assurance & Control | Process Optimization | Quality Management Systems
allendale, new jersey, united states
Website
Employees
150
AeroLeads page
4 roles

Mimi Bui work experience

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Associate Director, Qc Analytical & Microbiology

Current

Mountain View, California, United States

  • Specialized CDMO in Cell and Gene Therapy product development, clinical, and commercial manufacturing.In my most recent position, I was accountable for overseeing daily QC department operations, prioritizing analytical.
  • Achieved decrease in non-conformities, streamlined processes to eliminate non-value-added steps, and successfully implemented cost reduction measures.
  • Ensured regulatory compliance and client satisfaction by reviewing and approving change control activities. Supported QA and contributed to internal and client audits.
  • Established QC KPI metrics (OOS/OOT, invalid assay) for quality management review, assessing effectiveness and identifying improvement opportunities.
  • Closed significant process gap identified in client audit by spearheading project to assess, redesign, and implement efficient QC retains management process. Achieved approval within 30 days, conducted widespread.
Aug 2022 - Present

Senior Manager, Quality Control - Reagent

Santa Clara, California, United States

  • During my tenure as a Senior Manager QC, I implemented stability programs, validation procedures, and quality control processes for Rebus Biosystem, contributing to establishment and operational efficiency of startup..
  • Established and qualified QC lab equipment and materials for product readiness within a short timeline.
Dec 2021 - Jul 2022

Quality Control Manager

Fremont, California, United States

  • As a Quality Control Manager, I monitored QC personnel and laboratory operations for raw materials, reference standards and final Immunoassay products (Drug of Abuse/Therapeutic Drug Monitoring Reagent, Calibrator, and.
  • Spearheaded continual improvements in QC, ensuring compliance with QSR/ISO regulations, cGMP, and site goals.
  • Oversaw stability program for finished products and Reference materials, enabling product shelf-life date extensions and minimizing inventory scrap.
  • Contributed to successful new product transfers into production, met launch timelines, and coordinated stability activities.
Jun 2018 - Dec 2021

Qc Engineer/Scientist Lead

Fremont, California, United States

  • In this role, I led stability group, offering quality assurance support and technical expertise to internal departments and customers, ensuring product claims compliance with company standards.A small selection of.
  • Revitalized Stability monitoring testing in QC department by overhauling procedures, leading to 30% reduction in materials, time, and labor costs. Allowed QC personnel to engage in skill development, special projects.
  • Facilitated date extension requests from customers to prevent scrapping of high inventory, garnering positive feedback.
Jun 2007 - May 2018
Team & coworkers

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1 education record

Mimi Bui education

FAQ

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What company does Mimi Bui work for?

Mimi Bui works for Minaris Regenerative Medicine.

What is Mimi Bui's role at Minaris Regenerative Medicine?

Mimi Bui is listed as Quality Assurance & Control | Process Optimization | Quality Management Systems at Minaris Regenerative Medicine.

Where is Mimi Bui based?

Mimi Bui is based in Mountain View, California, United States while working with Minaris Regenerative Medicine.

What companies has Mimi Bui worked for?

Mimi Bui has worked for Minaris Regenerative Medicine, Rebus Biosystems, Thermo Fisher Scientific, and Thermofisher Scientific.

Who are Mimi Bui's colleagues at Minaris Regenerative Medicine?

Mimi Bui's colleagues at Minaris Regenerative Medicine include Almut Windhager, Patricia Morris, Christine Molokwu, Mariana Gutierrez, and Taiji Yahagi.

How can I contact Mimi Bui?

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What schools did Mimi Bui attend?

Mimi Bui holds Bachelor Of Science In Chemistry, Chemistry from Long Island University.

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