Proven experience in pharmaceutical processes, vaccine manufacturing, or laboratory Quality Control.
Strong quality assurance background, including deviation management, CAPA development, and document control.
Advanced critical thinking skills with the ability to solve complex technical problems in a regulated manufacturing or laboratory environment.
Strong technical writing skills, particularly for investigations, impact assessments, and other quality documentation.
Working knowledge of USDA and FDA regulatory expectations in manufacturing settings.
Foundational understanding of scientific disciplines such as Biology, Chemistry, Microbiology, Animal Science, Food Science, or Biochemistry.
Ability to collaborate effectively with cross-functional teams including Engineering, Production, TSMS, and laboratory staff.
Demonstrated ability to represent Quality during audits and inspections, providing clear, confident responses to technical and compliance questions.
Bachelor's degree in a science-related field such as Biology, Chemistry, Microbiology, Animal Science, Food Science, or Biochemistry, OR an Associate's degree with relevant industry experience.
Hands-on experience with Veeva quality systems.
Experience with SAP or similar enterprise resource planning systems.
Prior experience working in a USDA or FDA regulated manufacturing environment.
Knowledge of Lean and Six Sigma methodologies and their application to process improvement and defect reduction.
Experience with CAPA management, change control processes, and effectiveness checks in a regulated setting.
Background in laboratory operations, vaccines, and quality control testing.