Career Category

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.

The QA Specialist will be a member of the Amgen Thousand Oaks (ATO) Warehouse and Distribution Quality Team. The QA Specialist will provide Quality Assurance oversight for warehouse and supply chain operations for commercial and clinical biopharmaceutical products.

The QA Specialist will ensure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution, inventory management, and management of external relationships with Logistics Service Providers such as storage depots and transportation service providers.

The QA Specialist may also represent Quality in cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

Responsibilities include:

• Internal Quality Assurance support for GMP warehouse and inventory management operations

• Review and provide Quality approval for electronic and paper incoming material receipt records, and GMP documentation such as work orders, investigation reports, change control records, corrective action / preventive action records, and other GMP records

• Internal Quality Assurance support for creation and revision of GMP procedures including document review, approval, and archival

• Support investigations/deviation reports for warehouse operations and incoming materials

• Assess incoming product lots for compliance to specification requirements

• Manage QA product reserve sample inventory

• Alerts management of significant quality, compliance, supply, and safety risks

• Participates as a QA team member process during regulatory inspections, third party audits, and internal audits

• Makes certain the Quality Management System processes are implemented in accordance with established procedures

• The successful candidate will have experience working in multiple GMP databases

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

• Doctorate Degree OR

• Master's Degree & 3 years of cGMP experience OR

• Bachelor's Degree & 5 years of cGMP experience OR

• Associate's degree & 10 years of cGMP experience OR

• High school diploma/GED & 12 years of cGMP experience

Preferred Qualifications

• 3+ years of experience in a Quality Assurance role supporting GMP operations

• Previous experience with quality system transactions (SAP, SM-LIMS, Trackwise, VeevaVault)

• Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent

• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices.

• Proficient with database use, including data input, archival, and query retrieval

• Strong attention to detail and high degree of accuracy in task execution and GMP documentation

• Highly effective verbal and written communication skills, strong interpersonal skills

• Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues

Thrive

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.

Apply now

for a career that defies imagination

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

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