Career Category

Job Description

Responsible for providing oversight and leadership for Quality on-the-floor and operations support, the Specialist QA will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex investigations, change controls, and unexpected result investigations.  This role may be required to support shift work (day/night) as required. 

Responsibilities include:

 
•           Provide direct Quality Assurance support for all GMP activities (including on-the-floor quality oversight, raw materials release, deviations, change control and CAPAs) at ASM
•           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 indicator met targeted metrics

•           Perform comprehensive Quality review to support lot disposition of bulk drug substance

•           Act as one of the key Quality Contacts to resolve complex issues, adhering to Amgen policies and standards

•           Participate in root cause investigations for complex and significant deviations, leveraging various root cause analysis tools

•           Mentor and coach cross functional team members in order to establish a quality culture for routine operations

•           Participate in New Product Introduction (NPI) team to ensure robustness of product changeover as well as cross contamination controls  are in place
•           Participate in regulatory inspections, and interact directly with regulatory inspectors
•           Lead and support site/network driven QA continuous improvement initiatives/activities (e.g. supplier quality, stability program, product quality review, customer complaint investigation)

•           Escalate significant quality issues to Quality management in a timely manner

•           May act as delegate to Plant Quality Assurance (PQA) Shift Manager to support business needs

Basic Qualifications

Doctorate degree in Science and 2 years of directly related experience
OR
Master’s degree in Science and 5 years of directly related experience
OR
Undergraduate degree in Science and 8 years of directly related experience
OR
Undergraduate diploma in Science and 10 years of directly related experience

Preferred Qualifications

• Fluency in written and spoken English
• 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, 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.