Sr. Specialist, QA Operations
Core
Provide quality oversight and operational support for radiopharmaceutical manufacturing and validation activities in a GMP facility.
Role type
Senior QA Operations Specialist (GMP Manufacturing)
Builds
Radiopharmaceutical therapies for oncology patients
Domain
Biotechnology / Oncology / Radiopharmaceuticals
Required skills
GMP compliance, material and batch disposition, deviation/CAPA/change control management, regulatory documentation review, quality risk management, aseptic manufacturing knowledge, FDA/EMA regulatory knowledge
Preferred skills
Science degree (Biology/Chemistry/Engineering), experience in GMP aseptic manufacturing, experience with FDA or other regulatory authorities
Technologies
AI tools for productivity enhancement
Responsibilities
Review and approve deviations, CAPAs, change controls, batch records, and material disposition; perform real-time review of manufacturing records; conduct walkthroughs of manufacturing and QC areas; support audit and inspection response teams; provide guidance on shop floor quality activities
Seniority
Senior, hands-on IC