Career Category

Job Description

Associate, Quality Assurance

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:

• Provide direct Quality Assurance support for all GMP activities (including on-the-floor quality oversight, deviations, change control and CAPAs)

• Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicators meet targeted metrics
• Participate in root cause investigations for deviations
• Review of deviations, 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

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.