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Amgen Senior Associate Quality Assurance in Singapore, Singapore

Role Description:

  • Quality Professional with background and experience in commercial production of Biological drug substance to oversee night shift operations.

  • Conduct Quality Assurance activities related to quality floor support for solution and equipment prepartation, cell culture and product purification & Drug Substance Filling operations.

  • Support of electronic batch record review and approval, change control, investigations and product release

  • Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply

  • Role may include participation in new product introductions, additional equipment, installation commissioning, qualification.

  • Support continuous improvent initiatives

Education / Licenses

  • Degree in Chemistry, Chemical Engineering Science or related technological field

  • Doctorate degree & 2 years of directly related experience OR

  • Master’s degree & 2 years of directly related experience OR

  • Bachelor’s degree & 5 years of directly related experience

Relevant Experience

  • 4-6+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry

Competencies / Skills

  • Must have experience and understanding of GMP pharmaceutical production, biological drug substance experiance and operation preferred

  • Experience with batch record review, and quality record support

  • Experience in pharmaceutical equipment operation, design and control including GMP change control

  • Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production

  • Understanding of equipment log review and continuous monitoring requirements

  • Good communication skills (technical writing and verbal communication/presentation)

  • Interacts effectively with variety of communication and working styles

  • Experience with regulatory audits and inspections

  • Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

Additonal Requirements

  • Work on shift schedules will be required

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.