Chemical/Pharmaceutical, Quality Assurance (NIGHTS)
Core
Develop and implement a compliant quality system to assure PET radiopharmaceutical products are reliable, safe, and effective for patient treatment.
Role type
Mid-level Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
PET radiopharmaceuticals for disease diagnosis, staging, and monitoring
Domain
Healthcare / Pharmaceutical Manufacturing / Radiopharmaceuticals
Required skills
CGMP compliance, root cause analysis, gap assessments, quality planning, validation, CAPA, problem solving, documentation control, product release activities
Preferred skills
Pharmaceutical or medical device experience, ISO experience, 0-2 years in regulated environment
Technologies
None explicitly stated
Responsibilities
Review CGMP documentation for product release, facilities, equipment, and material controls; Establish and report metrics related to products and processes; Ensure site manufactures products to meet 21 CFR 212 (CGMP) requirements; Engage with operations to drive quality system requirements; Report quality system issues and discrepancies to regional RQM
Seniority
Mid-level, individual contributor
