Senior Associate Quality Complaints - Lab

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 Complaints - Lab

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out 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.

The Sr. Associate: evaluates complaint related return unit samples; maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP); performs work in a manner consistent with GLPs; executes day to day operations in the product complaint laboratory; and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

• Supports the mail center by monitoring and providing shipping material inventory as needed

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

• High school/GED + 4 years quality work experience OR

• Associate’s + 2 years quality work experience OR

• Bachelor’s + 6 months quality work experience

• Master's

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

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

• Ability to operate in a matrixed or team environment

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprisi