Development Scientist II, Analytical Development and Clinical QC (ADQC)

Job description

This is what you will do: This D evelopment Scientist I I will be a key team member in Alexion’s External A nalytical Development and Quality Control group. This position is responsible for maintaining the highest standard of quality and compliance of external quality control testing (GMP) laboratories. This candidate will be responsible for initiation and ownership of laboratory investigations (LIRs) through strong liaison with external contract laboratories and change controls relevant to ADQC biologic programs . The candidate will ensure timely , compliant, and high-quality delivery for LIR closure to enable the generation of final release CoAs . The role will work closely with internal Quality Assurance , Compliance, Analytical Development and Stability teams to ensure product to patients. You will be responsible for: Responsible for generating and/or mirroring , reviewing, providing assessments, and driving ownership of LIRs to close out Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results with structured root cause analysis, impact assessment, and/or corrective/preventive actions (CAPA s ) . D esign investigational testing plan s ensuring compliant closure of...