Senior Specialist - Quality Assurance - Nights
Core
Develop and implement a compliant and cost-effective quality system to assure PET radiopharmaceutical products and services are reliable, safe, and effective.
Role type
Senior Specialist Quality Assurance (cGMP)
Builds
PET radiopharmaceuticals for patient disease diagnosis, staging, and monitoring
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
cGMP compliance, root cause analysis, gap assessments, quality planning, validation, CAPA, problem solving, documentation control, product release, metrics reporting
Preferred skills
Chemistry or Biology degree, pharmaceutical or medical device experience, ISO experience, 1-2 years QA experience in regulated environment
Technologies
None stated
Responsibilities
Review CGMP documentation for product release, facilities, equipment, materials, and packaging; Establish and report metrics for products and processes; Ensure site manufactures products meeting 21 CFR 212 requirements; Manage quality documentation control, retention, and archival; Collaborate with operations to drive quality system requirements; Report quality system issues and discrepancies to regional RQM
Seniority
Mid-level Specialist, hands-on IC
