Sr. Specialist, Quality Assurance
Core
Develops and implements quality policies, procedures, and processes to ensure PET radiopharmaceutical products and services comply with regulatory standards and specifications.
Role type
Specialist, Quality Assurance (cGMP)
Builds
Compliant and cost-effective quality system for PET radiopharmaceutical manufacturing
Domain
Healthcare / Pharmaceutical Manufacturing / cGMP
Required skills
cGMP compliance, documentation review and control, product release activities, regulatory standards knowledge, quality metrics reporting, collaboration with operations
Preferred skills
Pharmaceutical or medical device experience, ISO experience, Bachelor's degree in science, 1-2 years QA experience
Technologies
cGMP documentation systems, quality management tools
Responsibilities
Review cGMP documentation for product release, facilities, equipment, and controls; Establish and report quality metrics; Ensure site manufacturing meets 21 CFR 212 requirements; Manage documentation control, retention, and archival; Collaborate with operations to drive quality system requirements; Perform product release activities; Report quality system issues and escalate discrepancies.
Seniority
Specialist, individual contributor
