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Sophia Koltusky Email & Phone Number

QA Specialist | Supplier Quality Management @ KBI Biopharma at KBI Biopharma
Location: San Francisco, California, United States 6 work roles 1 school
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✓ Verified May 2026 3 data sources Profile completeness 86%

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Role
QA Specialist | Supplier Quality Management @ KBI Biopharma
Location
San Francisco, California, United States
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Who is Sophia Koltusky? Overview

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Sophia Koltusky is listed as QA Specialist | Supplier Quality Management @ KBI Biopharma at KBI Biopharma, a company with 886 employees, based in San Francisco, California, United States. AeroLeads shows a matched LinkedIn profile for Sophia Koltusky.

Sophia Koltusky previously worked as QA Specialist I | Supplier Quality Management at Kbi Biopharma and Technical Writer | Senior Research Associate | Analytical Formulations Sciences at Kbi Biopharma. Sophia Koltusky holds Bachelor'S Degree, Human Biology from North Carolina State University.

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KBI Biopharma

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Profile bio

About Sophia Koltusky

As a dedicated Quality Assurance Specialist with over three years of experience in the biotechnology industry, I excel in maintaining high standards and ensuring compliance. I hold a B.S. in Biological Sciences and a Biomanufacturing certification from North Carolina State University.My career journey includes hands-on experience in analytical laboratory settings, where I conducted detailed validations and qualifications for test methods such as qPCR, ELISA, HPLC, and CE. This hands-on work equipped me with a strong foundation in scientific rigor and analytical skills.In addition to my lab experience, I have successfully managed projects, harmonizing study operations and testing activities for biopharmaceutical client products at various stages of clinical development. I led program management meetings, effectively communicating project progress to clients and stakeholders, and maintained thorough documentation of meetings and action items.My expertise extends to developing and negotiating supplier quality agreements, conducting thorough audits, and implementing strategic risk mitigation plans. I thrive on driving continuous improvement initiatives that enhance supplier performance and strengthen relationships.I enjoy making things better and building strong supplier relationships. Let's connect!

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KBI Biopharma
Kbi Biopharma
QA Specialist | Supplier Quality Management @ KBI Biopharma
durham, north carolina, united states
Employees
886
AeroLeads page
6 roles

Sophia Koltusky work experience

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Qa Specialist I | Supplier Quality Management

Current

United States

  • Develop and negotiate supplier quality agreements to enhance accountability and material quality
  • Collaborate with cross functional teams to analyze supplier risk and develop mitigation strategies for improved process performance
  • Assist in supplier qualification processes to ensure regulatory and quality compliance
  • Maintain up-to-date supplier documentation and generate performance reports
  • Conduct supplier audits to ensure compliance with quality standards and reduce non-conformances
Jul 2024 - Present

Technical Writer | Senior Research Associate | Analytical Formulations Sciences

Durham, North Carolina, United States

  • Managed cross-functional teams to deliver technical documentation projects on time and in compliance with regulatory requirements
  • Organized and maintained technical documents, including test methods, reports, certificates of analysis, and SOPs
Jun 2024 - Jul 2024

Senior Research Associate | Analytical Formulations Sciences

Durham, North Carolina, United States

  • Harmonized study operations and testing activities for data collection on 8 biopharmaceutical client products across various stages of clinical development
  • Led program management meetings, effectively communicating project progress to clients and stakeholders
  • Created detailed meeting agendas and maintained thorough documentation of meetings and action items for tracking and accountability
  • Optimized budget utilization by aligning program finances with project revenue
  • Drafted and executed validations and qualifications for test methods, including qPCR, ELISA, HPLC, and CE
Jul 2023 - Jun 2024

Research Associate Ii | Analytical Formulations Sciences

Durham, North Carolina, United States

  • Coordinated analytical training programs, managing logistics, scheduling, and material coordination to ensure trainees were well-versed in regulatory compliance
  • Exercised technical discretion in the execution and interpretation of assays, applying analytical expertise to contribute effectively to project goals and objectives
Jul 2022 - Jul 2023

Research Associate I | Analytical Formulations Sciences

Durham, North Carolina, United States

  • Executed current Good Manufacturing Practice (cGMP) analytical test methods using techniques including CGE, icIEF, HPLC, SDS-CGE, ELISA, qPCR, HIAC, and compendial methods
  • Maintained meticulous documentation of analytical testing procedures, observations, and results, adhering to Good Documentation Practices (GDP)
  • Performed peer reviews of data for analytical methods, ensuring compliance with FDA regulationsCoordinated study operations and testing activities for data collection for biopharmaceutical client products in various.
Jan 2021 - Jul 2022

Certified Nursing Assistant

Unc Rex Health Care

Raleigh, North Carolina, United States

  • Provided direct patient care under the supervision of registered nurses, ensuring comfort and safety for over 10 patients per shift
  • Assisted with daily living activities (bathing, feeding, and mobility) to support patient health
  • Monitored vital signs such as blood pressure, heart rate, and temperature, and reported any significant changes to the nursing staff
  • Maintained detailed and accurate patient records, documenting care provided and changes in condition
Dec 2019 - Feb 2021
Team & coworkers

Colleagues at KBI Biopharma

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1 education record

Sophia Koltusky education

FAQ

Frequently asked questions about Sophia Koltusky

Quick answers generated from the profile data available on this page.

What company does Sophia Koltusky work for?

Sophia Koltusky works for KBI Biopharma.

What is Sophia Koltusky's role at KBI Biopharma?

Sophia Koltusky is listed as QA Specialist | Supplier Quality Management @ KBI Biopharma at KBI Biopharma.

Where is Sophia Koltusky based?

Sophia Koltusky is based in San Francisco, California, United States while working with KBI Biopharma.

What companies has Sophia Koltusky worked for?

Sophia Koltusky has worked for Kbi Biopharma and Unc Rex Health Care.

Who are Sophia Koltusky's colleagues at KBI Biopharma?

Sophia Koltusky's colleagues at KBI Biopharma include Kaci Kennedy, Makiobo Mvula, Osama Sawaged, Erin Horne, and Luca Castelli.

How can I contact Sophia Koltusky?

You can use AeroLeads to view verified contact signals for Sophia Koltusky at KBI Biopharma, including work email, phone, and LinkedIn data when available.

What schools did Sophia Koltusky attend?

Sophia Koltusky holds Bachelor'S Degree, Human Biology from North Carolina State University.

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