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.

Specialist Quality Complaints

What you will do

Let’s do this. Let’s change the world. In this vital role you will conduct complex complaint investigations and own records with standard and advanced investigations. Specialist Quality Complaints defines the investigation strategy with the input from the cross functional team of subject matter authorities.

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.

• Evaluates and ensures triaged product complaint records stay in sync with applicable procedures.

• Evaluates and leads complaint records with standard and advanced investigations.

• Evaluates subject matter authority assessments and resolves if the cross functional team input is required.

• Coordinates and leads cross functional team meetings.

• Ensures quality of complaint records.

• Completes assigned assessments per applicable procedures.

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

• Anticipates and prevents potential issues with regulators.

• Provides guidance and technical advice during cross functional team meetings.

• Implements the complaint process per SOP requirements.

• Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide.

• Manages projects or project tasks as assigned to achieve agreed deliverables within time and with expected quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance.

• Provide training to staff on complaint handling procedures and regulatory requirements.

• Escalates 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:

• 4+ years of quality and/or manufacturing experience in biotech, medical devices or pharmaceutical industry.

• Bachelor’s Degree in a Science Field.

• 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.

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