Specialist Quality Complaints

Career Category

Quality

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.

What you will do

Let’s do this. Let’s change the world. In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution.

We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

• Ensures quality of complaint records

• Applies analytical abilities to evaluate complex situations using multiple sources of information

• Execution of regulatory and SOP requirements

• Anticipates and prevents potential issues with regulators

• Provides guidance and technical advice

• Evaluates subject matter expert assessments

• Raises potential Quality issues to Management

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree OR,

• Master’s degree and 4 to 6 years of Specialist Quality Complaints experience OR,

• Bachelor’s degree and 6 to 8 years of Specialist Quality Complaints experience OR,

• Diploma and 10 to 12 years of Specialist Quality Complaints experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Ability to oversee multiple projects simultaneously

• Ability to successfully handle workload to timelines

• Familiarity with basic project management tools

• Ability to negotiate a position after taking feedback from multiple sources

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

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.

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