Bachelor's degree in Biology, Chemistry, Biochemistry, or another Life Science discipline.
5+ years of experience in Quality Control within a regulated life sciences environment.
3+ years of experience overseeing external partners, CMOs, CROs, and/or contract testing organizations.
Experience supporting analytical method transfers, method qualifications, and method validations.
Strong understanding of GMP regulations and product testing requirements.
Experience supporting stability studies, including sample management, data review, and reporting.
Hands-on experience with investigations, deviations, change controls, OOS, and OOT events.
Proficiency with data trending and statistical analysis tools such as JMP and GraphPad.
Excellent organizational, documentation, and communication skills.