Sr. Specialist, Quality Control, Chemistry
Core
Senior Quality Control Chemistry professional ensuring scientific integrity, accuracy, and cGMP compliance of analytical data for product release and stability testing at Moderna's Madrid laboratory.
Role type
Senior IC Quality Control Chemistry Specialist
Builds
Analytical data packages, Certificates of Analysis, and stability data supporting mRNA product release
Domain
Biopharmaceuticals / Analytical Chemistry / cGMP
Required skills
Advanced analytical chemistry techniques (HPLC, UPLC, spectroscopy), Quality Event investigation (OOS, deviations), CAPA management, Change Control, Data Integrity, GxP compliance, Technical troubleshooting, Stability testing oversight
Preferred skills
Method qualification and development, Cross-functional leadership, Coaching junior staff
Technologies
HPLC, UPLC, DLS, Container Closure Integrity Testing (CCIT), Electronic records systems
Responsibilities
Review and approve analytical assay packages for product release; Lead investigations into Quality Events and OOS results; Define and monitor Corrective and Preventive Actions (CAPAs); Provide technical leadership during evening shift operations; Coordinate laboratory activities and scheduling; Support analytical method lifecycle activities; Generate and review Certificates of Analysis; Maintain GMP documentation and SOPs; Support regulatory inspections and audits.
Seniority
Senior, hands-on IC
