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!

Job Description

The Senior Associate Quality Assurance will assume the responsibility for supporting Quality System related deliverables for the External Quality Organization in support of Amgen’s network of Contract Manufacturers, Contract Labs and Suppliers. This individual will be working with cross-functional teams that includes members from Amgen Contract Manufacturing Operations, Supplier Quality Management, Process Development, and Supply Chain

Responsibilities:

• Own Quality records (Supplier Change Notifications, Change controls and deviations), manage and drive records to closure independently
• Ensure the record is documented in in GMP system completely per applicable SOPs.
• Understand and interpret of applicable GMP Regulations pertaining to the Quality systems or processes
• Perform LIMs data entry and other data entry related tasks
• Perform data verification of documents
• Provide support for External Quality Systems and processes
• Lead or participate on Quality System improvement projects
• Own and revise procedures
• Support metrics gathering
• Support the process of periodic monitoring of external suppliers
• Tracking and facilitation of the closure of External Supplier commitments
• Work cross functionally with ACM organization to execute to day-to-day responsibilities within QMS related systems.
• Support key deliverables and/ or projects as part of External Quality.
• Assure progress against commitments to regulatory agencies, identify compliance gaps and update all relevant procedures

Win

What we expect of you

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

Basic Qualifications:

• Masters Degree

• OR

• Bachelor's Degree and 2 years of Quality experience

• OR

• Associate's degree and 6 years of Quality experience

• OR

• High school diploma/GED and 8 years of Quality experience

Preferred Qualifications:

• 2+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Able to facilitate and influence team members clients and partners
• Strong project management, problem-solving, and analytical skills; experience with project management tools
• Able to successfully manage workload to timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
• Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Understanding of both Quality Systems and industry requirements/expectations of a NC, CAPA, Complaints and Change Control
• Experience in Root Cause Analysis
• Familiarity of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes, Supplier Quality Management)
• Experience driving timely decision making
• Demonstrated experience with Quality Systems, such as NC, CAPA, complaints and/or Change Control processes

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.

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Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.