Sr. Quality Associate Product Complaints Lab

Job Summary

The Sr. Quality Associate Product Complaints Lab executes day to day operations in the product complaint laboratory and ensures the daily workload is executed (e.g. PMs, calibrations, and general servicing).

Responsibilities include:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information
• 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.
• Perform return inspection for complaints and product security inspections

Basic Qualifications:

• Master's degree OR

• Bachelor's degree and 2 years of directly related experience OR

• Associate's degree and 6 years of directly related experience OR

• High school diploma / GED and 8 years of directly related experience

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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.