Specialist Quality Assurance Microbiology – Amgen

The Specialist Quality Assurance Microbiology position is now open at Amgen Singapore Manufacturing, located in Tuas. As a global biotechnology pioneer, Amgen has spent over four decades developing innovative human therapeutics and cutting-edge manufacturing capabilities. If you are ready to step into a vital leadership role within the fast-growing Japan and Asia Pacific (JAPAC) region, exploring this vacancy is your next definitive career milestone.

Role Overview

In this full-time, on-site role based in Singapore, the successful candidate provides crucial oversight and leadership for quality systems execution and operational support. You will champion manufacturing operations and in-process control (IPC) testing directly through presence on the manufacturing floor, spearheading complex quality resolutions.

Key Responsibilities

1. Quality Oversight: Provide direct Quality Assurance oversight to plant operations, ensuring the appropriate application and execution of GMP compliance and the Amgen Quality Management System.

2. Documentation Review: Lead routine GMP documentation review activities, including electronic batch records, SOPs, logbooks, work orders, batch production reports, and validation protocols.

3. Investigation Management: Participate in and review highly complex root-cause deviation investigations, unexpected result investigations, and corrective and preventive actions (CAPA).

4. Regulatory Support: Interact directly with regulatory inspectors and actively participate in international regulatory inspections.

5. New Product Introduction: Provide Quality Assurance support to the New Product Introduction (NPI) team and coach site QA professionals to resolve intricate problems.

Also Check: Regulatory Affairs Specialist – MSD

Requirements

1. Doctorate Degree: Holder in Microbiology, Biology, Biochemistry, or related sciences, OR

2. Master’s Degree: Plus 2 years of directly related quality or manufacturing experience, OR

3. Bachelor’s Degree: Plus 4 years of directly related experience, OR

4. Diploma: Plus 8 years of directly related pharmaceutical or biotech experience.

5. Core Competencies: Proven experience with regulatory inspections, cross-functional coaching, and complex deviation management.