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Amgen Principal Quality Engineer, Complaints Business Performance in Thousand Oaks, California

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Live

What you will do

Let’s do this! Let’s change the world!

Amgen is seeking a Principal Quality Engineer and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the 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 Principal Quality Engineer finds ways to prevent waste and inefficiency in processes. This role helps the complaint organization to identify and implement programmatic systems and processes, advance organizational capability development, and complete projects aligned with the functions’ strategic objectives to ensure long term success through continuous improvement and transformational capabilities. The Principal Quality Engineer designs efficient systems that integrate and assist in the prioritization and scheduling of workloads, identifying process improvements, and ensuring teams are managing daily activities most effectively. They also design processes to coordinate workload planning to minimize complaint processing issues and ensure complaint records are closed in a timely manner with the highest of quality standards. Designs, develops and maintains processing and oversight tools and practices to increase effectiveness, efficiency and space. Ensures the organization aligns with all standards for safety, quality, and compliance. Leads and/or works in a support role as needed on identified projects.

Key Responsibilities:

  • Reviews process information to understand methods and activities in the complaints and surveillance organization. This includes, but is not limited to, schedules, process flows and workflows.

  • Designs systems and tools to minimize and resolve processing issues and increase productivity.

  • Plans daily workload management to ensure all records and samples are processed in a timely manner

  • Develops processes to ensure productivity and efficiencies

  • Conducts daily stand-up meeting to ensure efforts are coordinated in an effective manner across working teams

  • Designs and implements capacity models to drive proactive planning and efficiency across the organization

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of professional experience in Quality, Manufacturing

Or

Master’s degree and 6 years of professional experience in Quality / Manufacturing

Or

Bachelor’s degree and 8 years of professional experience in Quality / Manufacturing

Or

Associate’s degree and 10 years of professional experience in Quality / Manufacturing

Or

High school diploma / GED and 12 years of professional experience in Quality / Manufacturing

Preferred Qualifications:

  • 8+ years of Industrial Engineering, quality and/or manufacturing experience in a relative industry (i.e., Biotech, Pharmaceutical, Automotive)

  • Quality and manufacturing experience in biotech or pharmaceutical industry

  • Bachelor’s Degree in Statistics, Mathematics and/or a Science Field

  • Strong background in statistics and complex statistical analysis

  • Industrial Engineering Degree

  • In depth knowledge of planning, prioritization, and scheduling tools

  • Knowledge of current Global regulations and their application

  • Understanding of Investigations and Root Cause Analysis

  • Understanding of the criticality of aligning target timeline and driving process improvements

  • Experience in planning, coordinating, and managing large throughput operations

  • Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes

  • Ability to work in a team matrix environment and independently interact with different levels of management

  • Good communication skills, both written and oral

  • Ability to create multi-functional networks/partnerships

  • Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives

  • A passion for managing for daily improvement

  • Indirect leadership skills and the ability to oversee multiple projects simultaneously

  • Able to successfully and independently manage workload, timelines, and priorities

  • Familiarity with advanced project management tools

  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership

  • Ability to travel +/- 10% of time to domestic and international Amgen sites

Thrive

What you can expect of us

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.

  • Vast opportunities to learn and move up and across our global organization

  • 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

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.

careers.amgen.com

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.

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