Amgen Sr Associate Quality Complaints in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Let’s do this. Let’s change the world.
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. Carries out 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).
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 and product security inspections
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.
Bachelor’s degree and 2 years of Quality experience
Associate’s degree and 6 years of Quality experience
High school diploma / GED and 8 years of Quality experience
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
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
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 demonstrates 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.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.
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.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.