Sophia Koltusky Email & Phone Number

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

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

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

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

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 stages of clinical trials

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