QA Associate (Contract/Biotech)

Responsibilities

• Support the execution of laboratory-based experiments in collaboration with Drug Substance and Process Development teams to enable small-scale model qualification, process investigations, and continuous process improvements.
• Plan, execute, and document laboratory studies, including data collection, analysis, and interpretation, in partnership with process scientists and engineers.
• Contribute to the preparation of technical reports, scientific documentation, and study summaries.
• Perform and/or coordinate laboratory purchasing activities, including purchase orders, invoice processing, and receipt of materials, while maintaining laboratory 5S standards.
• Ensure upstream Process Development laboratory readiness through the management of laboratory equipment and preventive maintenance programs.
• Support the introduction and qualification of new laboratory equipment while ensuring compliance with phase-appropriate GMP requirements.
• Contribute to new product introductions, process troubleshooting, and the optimization of existing and emerging biologics manufacturing processes at the Amgen Singapore Manufacturing (ASM) site.
• Participate in cross-training initiatives and provide support for downstream manufacturing operations as business needs require.

Basic Qualifications

• Educational background in Chemical Engineering, Bioprocess Engineering, Biochemistry, Biological Sciences, or a related discipline.

Preferred Qualifications

• Good laboratory knowledge and methodologies.
• Ability to work independently as well as collaboratively in a team environment.
• Demonstrate initiative, a positive work attitude, and a strong drive for continuous improvement.
• Familiarity with good documentation practices.

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