Job Description

Career Category

Quality

Job Description

Join Amgen's Mission to Serve Patients

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.

Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.

If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Specialist Quality Assurance I

What you will do

Responsible for providing oversight and leadership for quality systems execution and operations support, the Specialist Quality Assurance will support Facilities & Engineering (F&E), Quality Control (QC), Technology, Process Development (PD) or Validation (all non-direct manufacturing areas) for the Biologics and Synthetic Manufacturing plants.

Main Responsibilities:

• Provide quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning and qualification, regulatory approval and market supply
• Support routine GMP documentation review activities (e.g. SOPs, logbooks, work orders, validation documents, periodic reviews) and ensure key performance indicator met targeted metrics
• Co-lead and support the deployment of Amgen quality systems, including management review, validation, deviation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
• Review and approve deviations, investigations, testing result investigations, change controls, and other quality records (with focus on highly complex records). Participate in and lead complex root cause investigations for deviations
• Lead Quality Assurance oversight in commissioning and qualification projects or New Product Introduction (NPI)
• Coach site Quality Assurance professionals on resolution of quality issues
• Participate in regulatory inspections and interact directly with regulatory inspectors
• Lead or support function/site/network initiatives and continuous improvement projects

What we expect of you

• Doctorate Degree
• Master’s degree and 2 years of experience in pharmaceutical company or GMP environment OR
• Bachelor’s degree and 4 years of experience in pharmaceutical company or GMP environment OR
• Diploma and 8 years of experience in pharmaceutical company or GMP environment
• Preferred 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
• Direct experience with bulk manufacturing of biopharmaceuticals/API 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. People and stakeholder management.
• 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.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

What you can expect of us

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

Apply now and help transform the lives of patients while transforming your career.

careers.amgen.com

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 and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation