Principal Analytical QA Specialist, Drug Substance
Core
Provide Quality Assurance oversight of GMP manufacturing, release, stability, validation, and lifecycle management for veterinary pharmaceutical drug substances and products.
Role type
Principal Analytical QA Specialist (Drug Substance)
Builds
Veterinary pharmaceutical products (drug substance and drug product) for FDA approval and commercialization
Domain
Veterinary pharmaceuticals / Drug Substance Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP QA oversight, analytical method validation, batch release management, regulatory compliance (FDA CVM, cGMP, VICH), CDMO management, quality event investigation, data integrity assessment
Preferred skills
RAC or ASQ certification, supplier/CDMO auditing, small molecule development, solid oral dosage forms, international regulatory environments (EU, Canada), electronic Quality Management Systems
Technologies
Google Workspace applications, electronic Quality Management Systems
Responsibilities
Oversee analytical method development, qualification, validation, transfer, release testing, and stability programs; Review and approve validation protocols, raw data, and reports; Manage batch release program by reviewing documentation and quality events; Lead or support quality event resolution investigations (OOS/OOT, deviations); Perform data integrity assessments for regulatory submissions; Maintain communication with CDMOs and CTLs
Seniority
Principal, hands-on IC with strategic oversight
