Senior Officer - QC

Role & responsibilities

• Empower 3 Operation: Configure sample sets, create sample queues, and run analysis sequences using Empower 3 software.
• Method & Integration: Apply processing methods, optimize integration parameters (peak width, threshold), and manage custom chromatographic calculations within Empower.
• Data Processing: Review raw data, evaluate system suitability parameters (tailing factor, plate count, %RSD), and sign off on electronic data.
• Data Integrity: Enforce ALCOA+ principles by maintaining secure user sessions, tracking electronic signatures, and complying with Empower 3 Audit Trails.
• Sample Testing: Analyze raw materials, stability samples, and finished products using HPLC units (Waters Alliance/Arc/Acquity systems preferred).
• Documentation: Document results concurrently via Empower report publishers, lab notebooks, and Laboratory Information Management Systems (LIMS).
• OOS Handling: Identify and escalate Out-of-Specification (OOS) data generated in Empower; support investigations with audit trail data reviews.

Preferred candidate profile

Preferred Candidate: Background in Pharmaceutical API manufacturing and Quality Control.