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.

Sr. Associate QA

Live

What you will do

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

The Sr. Associate QA will be a member of the Amgen Thousand Oaks (ATO) Incoming Quality Assurance Team. The Sr. Associate QA will be responsible for the inspection, sampling and batch record review of raw materials, and commercial and clinical biopharmaceutical products.

The Sr. Associate QA provide Quality Assurance oversight for warehouse and supply chain operations for commercial and clinical biopharmaceutical products.

The Sr. Associate QA will provide guidance and direction to Production, Warehouse/Distribution staff in regards to compliance with quality policies, standards and procedures.

The Sr. Associate QA 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

• Perform inspection and sampling of raw materials, and commercial and clinical biopharmaceutical products

• Review and provide Quality approval for electronic and paper incoming material receipt records, and GMP documentation such as work orders, investigation reports, deviation 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, incoming raw material receipts

• Assess incoming product lots for compliance to specification requirements

• Provide support for QA Reserve inspections and management

• 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

• 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

• Master's Degree OR

• Bachelor's Degree & 2 years of cGMP experience OR

• Associate's degree & 6 years of cGMP experience OR

• High school diploma/GED & 8 years of cGMP experience

Preferred Qualifications

• Quality and Manufacturing experience in biotech or Pharmaceutical industry

• Bachelor’s Degree in Science field

• Familiarity with basic project management tools

• Ability to successfully manage workload to timelines

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

• 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.

careers.amgen.com

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Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally used formal coaching document or (b) their most recent performance rating was not a “Partially Meets Expectations” or higher. Please visit our Internal Transfer Guidelines for more detailed information