Kelomi Swint
College Station,TX
Summary
Led quality audits and inspections to identify deviations and manage corrective action processes effectively. Oversaw regulatory inspections to maintain compliance standards. Partnered with cross-functional teams to enhance quality initiatives and mitigate regulatory risks.
Overview
10
10
years of professional experience
1
1
Certification
Work History
QA Soecialist III Audit & Inpection
FUJIFILM Diosynth Biotechnologies
06.2025 - Current
- Executed comprehensive internal and external audits to uphold industry compliance standards.
- Directed and coordinated regulatory inspections to ensure compliance and operational readiness.
- Directed compliance oversight for standard operating procedures (SOPs), good manufacturing practices (GMP), and company policies.
- Conducted thorough identification of non-conformances and implemented root cause analysis to resolve underlying issues.
- Compiled and analyzed comprehensive audit reports to ensure compliance with regulatory standards.
- Directed cross-functional team collaboration to enhance process efficiency and mitigate risks.
- Oversaw monitoring and tracking of corrective actions to ensure timely resolutions.
- Spearheaded audit readiness initiatives through systematic inspections and compliance evaluations across departments.
- Facilitated staff training sessions focused on regulatory compliance and quality assurance standards.
Quality Assurance Analyst
FUJIFILM Diosynth Biotechnologies
09.2024 - 12.2024
- Maintained comprehensive knowledge of relevant industry regulations and standards to ensure compliance throughout QA process.
- Executed comprehensive document reviews to pinpoint inaccuracies and inconsistencies.
- Collaborated with subject matter experts to validate technical content in documentation projects.
- Facilitated regular meetings with cross-functional teams to discuss progress updates and address challenges.
- Assisted in reviewing lab notebooks for compliance with protocols. Supported audits of equipment logbooks to maintain accurate records. Collaborated with team members to ensure proper documentation practices.
Quality Assurance Document Control
Catalent Pharma Solutions
12.2021 - 06.2024
- Provide regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies utilizing KPIs
- Determine root cause of deviations and non-conforming results and implement appropriate CAPA to reduce deviations by 23%.
- Managed product complaints and implemented corrective actions to prevent recurrence.
- Guaranteed the availability and accuracy of documentation for customer audits, ensuring regulatory compliance and enhancing customer satisfaction through transparent and efficient processes.
- Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and SOP requirements.
- Assist in the development of paperless batch records via Salesforce
- Authored technical documents, including SOPs, protocols, and training materials.
Quality Management System
Clinigen
05.2020 - 11.2021
- Oversaw incoming inspection, disposition and life cycle for all clinical supplies.
- Responsible for the inspection, disposition and maintenance of Clinical Trial Labels.
- Hosted customer audits ensuring confidentiality agreement is in place, scheduled audits, requested audit agenda, and provided relevant documentation in advance.
- Perform in-process audits ensuring materials are produced according to quality standards and established quality systems.
- Collaborated with management to provide training on improved processes and assist with creation and maintenance of quality training.
- Conducted internal audits and managed corrective actions.
- Played an instrumental role in preparing the organization for successful third-party audits by diligently addressing any areas of non-compliance or concern.
- Maintained accurate records of audit findings, allowing for effective tracking of progress toward quality goals and identification of recurring issues.
Production Coordinator
Almac Clinical Technologies
10.2016 - 04.2020
- Met aggressive production and safety goals while minimizing equipment downtime.
- Inspected, verified and documented quantifiable characteristics of finished goods, comparing against customer specifications and company quality standards to achieve acceptable product.
- Accurately and timely complete the review/auditing of executed batch records ensuring that quality has been deemed satisfactory throughout manufacturing/assembly/labeling process.
- Addressed internal supply problems head-on and developed creative solutions to prevent delays and missed targets.
Education
Associate of Arts - Liberal Arts And General Studies
Montgomery County Community College
Blue Bell, PA05.2016
Skills
- TrackWise
- KPI
- Salesforce
- MasterControl/Veeva
- Risk Management
- CGMP and GDP
- CAPA & Deviations
- Project Management
- Change Orders
- JD Edwards
- MicroSoft Excel
- Auditing
Certification
- Project Management Training - 2022
- Six Sigma: Green Belt Training - 2022
Timeline
QA Soecialist III Audit & Inpection
FUJIFILM Diosynth Biotechnologies
06.2025 - Current
Quality Assurance Analyst
FUJIFILM Diosynth Biotechnologies
09.2024 - 12.2024
Quality Assurance Document Control
Catalent Pharma Solutions
12.2021 - 06.2024
Quality Management System
Clinigen
05.2020 - 11.2021
Production Coordinator
Almac Clinical Technologies
10.2016 - 04.2020
Associate of Arts - Liberal Arts And General Studies
Montgomery County Community College