Job Abstract

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr. Quality Assurance Engineer 

What you will do

Let’s do this. Let’s change the world. In this vital role you will be accountable to provide Quality oversight of CPO method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to CPOQ CORE and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites.

• Co-develop training materials for stability method transfers with CPO
• Ensures activities are in line with budget and support evidence-based resource needs
• Provides Quality oversight to CPO activities and results (A)
• Quality approval of protocols and technical reports for method development (D)
• Provides advice to inform Quality Plan (A)
• Provides advice and expertise to inform development of technical training materials for method transfer (A)
• Oversight of protocols and requirements to outsource testing to labs (A)
• Approved method development, validation, and transfer reports
• Robust change controls, CAPAs, and NCs
• Successful CPO method stewardship deliverables
• Method training materials
• Reports to manager CPOQ Core in Thousand Oaks.
• Key advisor to Core Technologies Lead
• Advisor to Innovation and Development Leads
• Advisor to site quality organizations
• Advisor to Product Quality Leaders (PQLs)
• Collaborate with and/or provide advice to Regulatory to inform submissions
• Align with Attribute Sciences where similar networks or governances are established
• Collaborate with External Supply Quality to ensure plans in place when receiving methods from a CMO or suppliers

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.

Doctorate degree

Master’s degree and 2 years of quality experience

Bachelor’s degree and 4 years of quality experience

Associate’s degree and 8 years of quality experience

High school diploma / GED and 10 years of quality experience

• 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• Experience in developing physical methods for combination products
• Familiarity with force measurement equipment, dimensional analysis, calibration, and lab GLP
• Leadership skills and the ability to coordinate multiple projects simultaneously
• Familiar with combination products including applicable guidance, regulations and standards e.g. ISO 14971, ICH Q8, ICH Q9, ICH Q10, ICH Q12, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211Working knowledge of calibration standard ISO 17025
• Ability to discern user requirements for input to method development
• Able to successfully manage workload to timelines

What you can expect of us

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

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

careers.amgen.com

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 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 accommodation.

Salary Range