Senior Specialist - Quality Assurance - Nights
Core
Develop and implement a compliant quality system to ensure PET radiopharmaceutical products are reliable, safe, and effective for patient treatment.
Role type
Quality Assurance Specialist (cGMP)
Builds
PET radiopharmaceuticals for patient diagnosis, staging, and monitoring
Domain
Healthcare / Radiopharmaceuticals / Quality Assurance
Required skills
cGMP compliance, root cause analysis, gap assessments, quality planning, validation, CAPA, product release, documentation control, metrics reporting
Preferred skills
Chemistry or Biology degree, pharmaceutical or medical device experience, ISO experience, night shift availability
Technologies
21 CFR 212, CGMP, ISO
Responsibilities
Review CGMP documentation for product release, establish and report quality metrics, ensure site compliance with 21 CFR 212, manage quality documentation control and retention, collaborate with operations on quality systems, report quality system issues and discrepancies
Seniority
Mid-level, individual contributor
