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Job Description

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.

Live

What you will do

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

Amgen is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to our Sr. Manager of Complaints Trending and Investigation. In support of Amgen’s mission to serve patients, the Complaints Trending and Investigation group at Amgen is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The complaints investigation technical investigator will lead and perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, and Instron testing machines. S/he will be responsible for training new personnel, tracking and monitoring the assessments to ensure completion on time, authoring and reviewing the assessment report, and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis as well as supporting root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the CT&I lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, leading the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Responsibilities:

• Lead the device assessments of complaints and document results in a report using the electronic lab notebook.

• Train and support onboarding of new personnel in performing device assessments and use of the CT&I equipment.

• Complete evaluation and deliver assessment report on time per Amgen requirements.

• Support the implementation and management of the lab infrastructure, including all equipment used for investigations and lead monthly lab safety inspections

• Provide requirements for lab and investigational equipment to device development teams in support of new device platforms and development of test methods

• Perform characterization testing and support data gathering for investigations

• Support root cause analysis investigations for mechanical and/or electromechanical products

Win

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

• Master’s degree; OR

• Bachelor’s degree and 2 years of related medical/biopharma development or Operations experience; OR

• Associate degree and 6 years of related medical/biopharma development or Operations experience.

• High school diploma / GED and 8 years of related medical/biopharma development or Operations experience

Preferred Qualifications

• Master’s or Bachelor’s in Engineering, Science or Biomedical

• 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment

• Experience in lab environment

• Demonstrated competency in root cause analysis methodology

• Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)

• Strong technical writing and interpersonal skills

• Results-driven and meticulous team leader

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.

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 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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com