Senior Associate Quality Assurance

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Quality Assurance - Global Supply Quality

What you will do

Let’s do this. Let’s change the world. In this vital role you will The Sr. Associate QA position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen cross-functional raw materials suppliers’ team that includes but is not limited to business operations, analytical science, process development, and supply chain.

Responsibilities:

Working independently, the individual will be responsible for, but not limited to the following:

• Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation

• Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP.

• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations

• Collaborate with raw material suppliers to ensure adherence to quality agreements, identifying performance improvement opportunities

• Understand and incorporate risk management strategy into the overall raw material lifecycle

• Provide support to the supplier periodic monitoring oversight activities

• Support in tactical activities related to internal/external audits and inspections

• Perform routine quality assessments and provide approval of changes to raw material inspection profiles

• Take part in operational improvement initiatives, programs, and projects

• Develop solutions that are thorough, practical, and consistent with functional objectives

• Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.

• Work under minimal supervision in line with Amgen Values and Leadership Attributes.

• This role may require working in shifts or extended hours within the same shift to support global timezones.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Master’s degree and 1 to 3 years of professional experience in related fields OR

• Bachelor’s degree and 3 to 5 years of professional experience in related fields OR

• Diploma and 7 to 9 years of professional experience in related fields

• Understanding of GMP/GDP requirements.

• Familiarity with raw material compendial testing

• Experience overseeing quality of suppliers or external parties

• Strong technical writing skills

Preferred Qualifications:

• Experience and strong familiarity with digital tools and computerized systems.

• Strong continuous improvement approach and lean practices experience.

• Understanding of end-to-end supply chain business processes.

• Experience in project management across multiple departments and geographies.

• Quick process understanding, insight and visualizing.

• Strong analytical and problem-solving skills.

• Independent self-starter, able to work autonomously, under pressure and in teams.

• GMP/GDP knowledge and understanding of pharmaceutical regulations.

• Energetic, detail oriented, highly motivated with a “can do” outlook.

• Change management skills.

• Ability to communicate across all levels of the organization.

• Effective written and verbal communication skills.

• Experience with Microsoft Office Tools including Excel, Word, and PowerPoint.

• Ability to multi-task and prioritize

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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 to 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.