Amgen Associate QA I in Singapore, Singapore

Responsible for providing oversight for Quality on-the-floor and operations support, the Associate QA will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform 12-hour shift (day/night).

Responsibilities include:

  • Support the maturation and continuous improvement of Amgen quality systems, including On-the-floor quality oversight, raw materials release, non-conformances, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations

  • Participate in root cause investigations for non-conformances

  • Review of nonconformance investigations, change controls, and other quality records (with focus on highly complex records) such as electronic batch records, SOPs, logbooks and work orders

  • Support in regulatory inspections, and interact directly with regulatory inspectors

  • Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation

Basic Qualifications

Doctorate degree in Science and 1 years of directly related experience

OR

Master's degree in Science and 1-2 years of directly related experience

OR

Undergraduate degree in Science and 1-3 years of directly related experience

OR

Undergraduate diploma in Science and 5 years of directly related experience

Preferred Qualifications

  • Fluency in written and spoken English

  • 1-3 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems.

  • Direct experience with bulk manufacturing of biopharmaceuticals preferred.

  • Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff