Product Quality Specialist
Core
Provide technical expertise and product leadership to the Product Quality organization, supporting late-stage and commercial biologics or synthetics products.
Role type
Product Quality Specialist (Pharmaceutical Sciences)
Builds
Biologics and synthetic medicines
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, scientific data management, regulatory document authoring, stability assessment, comparability assessment, periodic and annual product review (APR), complaint resolution, GMP system execution
Preferred skills
Veeva, Spotfire, SHINY, MS Office (Word, Excel, PowerPoint, MS Teams), virtual multi-functional team collaboration
Technologies
Veeva, Spotfire, SHINY, MS Teams
Responsibilities
Support product specifications, in-process controls, periodic and annual product reviews, and complaint resolutions; execute transactions in GMP systems; manage product data including stability and comparability assessments; author and review GMP and regulatory documents.
Seniority
Mid-level, hands-on IC
