Summary
Overview
Work History
Education
Skills
Certification
Awards
Timeline
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Afton Starling

Afton Starling

Fuquay-Varina,NC

Summary

Experienced validation engineering professional with 10 years of industry expertise. Strong background in process and equipment validation, quality assurance, and regulatory compliance. Known for promoting team collaboration, ensuring project success, and adapting to changing demands. Skilled in creating and executing validation protocols, troubleshooting issues, and maintaining high standards. Reliable team player with a results-driven mindset and excellent problem-solving abilities.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Validation Engineer

Kymanox
01.2021 - Current
  • Support validation activities for facilities, utilities, processes, analytical methods, and equipment, ensuring compliance with GAMP 5 and ISO standards.
  • Develop and implement the full validation lifecycle in alignment with industry guidelines, including authoring and executing requirement specifications and qualification protocols (URS, FRS, DS, DR, IQ, OQ, PQ, TMX) to support Commissioning, Qualification, and Validation (CQV) efforts.
  • Experience in using various Quality Management Systems (QMS) software including Veeva Vault, MasterControl, and DOT Compliance, to manage documentation, training, and quality workflows.
  • Author validation plans, deviations, Standard Operating Procedures (SOPs), and prepare comprehensive final summary reports for equipment validation activities.
  • Proficient in using Smartsheet and Laboratory Information Management Systems (LIMS) for project tracking and data management.
  • Competent in Kneat software with Level One Power User Certification, demonstrating advanced capability in digital validation and document management.
  • Conduct thermal validation projects to ensure temperature controlled environments meet specified product safety, efficacy, and quality requirements using Kaye software.
  • Manage end-to-end change control processes, including initiation, risk assessment, impact analysis, implementation, verification, and closure, ensuring compliance with regulatory and quality standards.
  • Served as Project Manager leading CQV projects, managing planning, budgeting, and cross-functional team coordination to ensure timely and successful project delivery.
  • Train and mentor junior engineers in best practices for validation engineering methodologies improving team skillsets.
  • Ensure strict adherence to Good Manufacturing Practices (GMP) in all laboratory operations and documentation.

Research Scientist

Metabolon
01.2016 - 01.2021
  • Operated LC-MS and ICP-MS instruments daily, including performing routine maintenance and system performance checks to ensure optimal functionality.
  • Streamlined research processes to meet tight deadlines for multiple projects.
  • Analyzed sample data using in-house LIMS software and prepared detailed reports for submission to the data curation team while ensuring proper maintenance and performance of laboratory instruments.
  • Collaborated with vendors to procure equipment and supplies in alignment with laboratory requirements.
  • Prepared solutions and calibration standards to support accurate instrument operation.
  • Executed Installation and Operational Qualifications (IOQs) for all new analytical instruments.
  • Performed Performance Qualifications (PQ) on analytical instruments to ensure they met operational standards.
  • Calibrated instruments prior to sample analysis to ensure data accuracy and reliability.
  • Authored and followed Standard Operating Procedures (SOPs) to ensure consistency and compliance in laboratory practices.
  • Mentored junior scientists, fostering professional growth and enhancing team capabilities.

Associate Scientist

Metabolon
01.2015 - 01.2016
  • Received, accessioned, and processed biological samples for analysis on various analytical platforms.
  • Performed precise sample measurements, including pipetting and weighing of biological materials.
  • Worked with cross-functional project teams to support sample analysis workflows.
  • Operated laboratory robotics and instrumentation to support chemical extraction and reconstitution of biological samples and extracts.
  • Conducted biological assays and compiled data into reports for the project director and other stakeholders.
  • Maintained a safe and organized laboratory environment by adhering to best practices for chemical handling and waste disposal.
  • Managed the sorting and tracking of incoming client samples to ensure accurate workflow and documentation.
  • Monitored and maintained laboratory consumable inventory to support uninterrupted operations.
  • Managed multiple projects simultaneously, demonstrating exceptional time management skills while maintaining high levels of accuracy.

Medical Technologist

Harnett Health Systems
07.2013 - 09.2015
  • Followed laboratory protocols for specimen processing, analysis, and results reporting.
  • Analyzed laboratory findings to check accuracy of results.
  • Enhanced patient care by accurately performing and interpreting laboratory tests in hematology, chemistry, microbiology, and blood bank departments.
  • Reduced turnaround time for test results by efficiently processing specimens and maintaining optimal instrument performance.
  • Maintained strict adherence to safety protocols, minimizing the risk of infection or contamination in the laboratory environment.
  • Operated, calibrated, and maintained sophisticated instruments and equipment to facilitate quality laboratory and patient care operations.
  • Increased efficiency by troubleshooting equipment malfunctions and performing routine maintenance tasks as needed.
  • Contributed to the overall success of the laboratory by maintaining a positive attitude and demonstrating strong teamwork skills in daily interactions with peers.

Analytical Chemist

North Carolina State Laboratory of Public Health
03.2008 - 08.2013
  • Developed and optimized sample preparation techniques to ensure accurate results while minimizing potential contamination.
  • Performed sample accessioning for up to 1,000 samples per day, ensuring accurate tracking and data entry in compliance with laboratory protocols.
  • Conducted trace element analysis of blood samples using Inductively Coupled Plasma Mass Spectrometry (ICP-MS).
  • Improved accuracy of results by maintaining calibration records and performing routine instrument maintenance.
  • Communicated analytical results to relevant departments and physicians to promptly report potential patient poisoning cases.
  • Authored Standard Operating Procedures (SOPs) to support consistent laboratory and state regulatory compliance.
  • Examined inoperative or malfunctioning analytical equipment to diagnose source of trouble.

Education

Bachelor of Science - Biological Sciences

North Carolina State University
Raleigh, NC
05.2007

Skills

  • Effective Communication Skills
  • Equipment Qualifications
  • Thermal Validations
  • Validation Plans and Protocols
  • CAPA Management
  • Quality Management Systems (QMS)
  • Change Control
  • Computer System Validation (CSV)
  • ISO and GAMP Standards
  • GxP Compliance
  • Risk Assessments
  • Technical Writing

Certification

Kneat: Level One Power User

Awards

Issued by Kymanox · Apr 2023

Swiss Army Knife Award

  • Awarded the 'Swiss Army Knife' award in recognition of consistently demonstrating team-oriented leadership, stepping up when needed, and willingly taking on diverse roles to support project and team success.


Issued by Kymanox · Aug 2024

Load Bearer: Lean On Me Sage Award

  • Received the 'Lean on Me' award at the annual company meeting in recognition of outstanding reliability and team support.

Timeline

Validation Engineer

Kymanox
01.2021 - Current

Research Scientist

Metabolon
01.2016 - 01.2021

Associate Scientist

Metabolon
01.2015 - 01.2016

Medical Technologist

Harnett Health Systems
07.2013 - 09.2015

Analytical Chemist

North Carolina State Laboratory of Public Health
03.2008 - 08.2013

Bachelor of Science - Biological Sciences

North Carolina State University

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Afton Starling