Manager Quality Control (Micro and Sample Management)

Overview

Amgen Singapore Manufacturing is hiring a Manager, Quality Control (Micro and Sample Management). The role focuses on overseeing QC Microbiology shift teams, ensuring compliance with cGMP and related regulations, and supporting microbiology testing and sample management across biologics and small molecule manufacturing.

Responsibilities

• Lead and supervise QC Microbiology staff, maintain weekly lab schedules, and prioritize daily work tasks.
• Provide quality oversight to ensure processes follow cGMP and regulatory requirements.
• Review, approve, and track cGMP documents, including nonconformance records and CAPAs.
• Oversee day‑to‑day microbiology activities: environmental monitoring, raw material and product testing (bioburden, microbial limits, endotoxin, qPCR, microbial ID), media and reagent qualification, sample logging and processing.
• Manage sample management and stability activities, including sa...