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Specialist Quality Complaints


This is a Contract position in Los Angeles, CA posted June 15, 2022.


Youve earned your degree.

How will you use that achievement to reach your goals?

Do more with the knowledge youve worked hard to acquire and the passion you already have.

At Amgen, our shared missionto serve patientsdrives all that we do.

It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide.

Become the professional you are meant to be in this meaningful role.

Specialist Quality Complaints Live What you will do Lets do this.

Lets change the world.

In this vital role you will own and executes the end-to-end global complaint investigation 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 Facilitate cross-functional meetings to plan and coordinate the plan for investigation and closure of records Applies analytical skills and product knowledge to evaluate sophisticated situations using multiple sources of information Executes against prioritized work plans Quickly escalates issues that could impede the ability to close records according to investigation plans Maintains compliance with local and global processes Execution of regulatory and SOP requirements Anticipates and prevents potential issues with regulators Provides mentorship and technical advice Evaluates subject matter expert assessments Escalates potential Quality issues to Management Have experience managing quality investigation including Root Cause Analysis Support regulatory agencies inspections from the perspective of the complaint investigation process Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.

The Specialist Quality Complaints professional we seek is a dynamic individual with these qualifications.

Doctorate degree Or Masters degree and 3 years of Quality / Manufacturing experience Or Bachelors degree and 5 years of Quality / Manufacturing experience Or Associate degree and 10 years of Quality/Manufacturing experience Or High School/GED and 12 years of Quality/Manufacturing experience Beyond that, the additional preferred qualifications are: 4 years of quality and manufacturing experience in biotech or pharmaceutical industry Bachelors Degree in a Science Field Ability to supervise multiple projects simultaneously Ability to efficiently lead workload to timelines Basic project management tools Ability to negotiate a position after taking feedback from multiple sources Proven ability to consistently deliver timely, 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) Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, so we 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 maximize 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.

Join us. 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.