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.

Specialist QA

Live

What you will do

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

The QA Specialist position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of operational activities associated with and supporting the Drug Product manufacturing areas at Amgen, Thousand Oaks.

Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes, procedures, and use of quality systems. Duties include purposeful presence on the shop floor, electronic batch record creation, batch record review, SOP revision approval, work order approval, and quality approval of deviations and CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Specialist will also represent functional area quality for the Drug Product Quality Assurance department in the implementation of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Responsibilities:

• Provides Quality Oversight of on the floor activities including manufacturing operations, testing, and inspecting of Drug Product.

• Performs Batch Record review and approval

• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations

• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams

• Reviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports

• Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.

• Participates in Amgen internal/external audits and inspections. May directly interact with regulatory agencies during on-site inspections.

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

Or

Master’s degree and 3 years of Quality and/or Manufacturing experience

Or

Bachelor’s degree and 5 years of Quality and/or Manufacturing experience

Or

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

Or

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

Preferred Qualifications

• Bachelor’s Degree in Science

• 5 plus years of aseptic processing experience in QA or Manufacturing

• Excellent interpersonal, verbal and written communication skills with all levels within the organization

• Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis.

• Strong leadership capabilities and proven experience applying GMP requirements in an operational setting

• Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

• Applies project management principles and techniques.

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 sophisticated 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 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 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