Amgen Inc

Sr Quality Engineer - Physical Methods

Amgen Inc • $114K — $154K *
Boston, MA 02115In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Doctorate OR Master's with 4-6 years OR Bachelor's with 6-8 years OR Diploma with 10-12 years of Quality experience.
  • Deep knowledge of quality systems including change control and risk management.
  • Experience in biotechnology or medical device quality and manufacturing.
  • Familiarity with combination-product development methods and regulations.
  • Advanced technical-writing and analytical skills.

Responsibilities

  • Co-develop training materials with CPO to enhance method understanding.
  • Ensure compliance with budget and provide resource assessments.
  • Oversee the validation of physical test methods and sample-selection strategies.
  • Provide quality direction on deliverables and CPO activities.
  • Review and approve protocols and technical reports related to method lifecycle management.
  • Guide the creation of technical training for method transfers.
  • Serve as QA representative for change controls and non-conformance issues.

Benefits

  • Comprehensive Total Rewards Plans.
  • Support for professional and personal growth.
  • Collaborative workplace culture.
Full Job Description
Career Category
Quality
Job Description

Sr. Quality Assurance Engineer

Live

What you will do

Let's do this. Let's change the world. In this vital role you 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.

Responsibilities:
  • Co-develop method training materials in partnership with CPO.
  • Ensure activities align with approved budgets and provide evidence-based input for resource needs.
  • Provide quality oversight for the development, maintenance, transfer, and validation of physical test methods, including sample-selection strategies.
  • Provide quality guidance on CPO activities, deliverables, and results.
  • Review and approve protocols and technical reports supporting method development, transfer, validation, and lifecycle management.
  • Advise on technical training materials supporting successful method transfer.
  • Oversee documentation, records, and requirements for in-house and/or outsourced testing laboratories.
  • Review and approve controlled documentation through Veeva-CDOCS.
  • Serve as the QA representative for change controls, CAPAs, non-conformances, and deviations.
  • Support effective CPO method stewardship throughout the method lifecycle.
  • Act as a key advisor and owner for continuous improvement, root-cause analysis, and problem solving.
  • Advise Innovation and Development Leads, site organizations, and Product Quality Leaders.
  • Collaborate with Regulatory partners to support product submissions and related documentation.
  • NOTE: Work third shift to provide primary support for multisite teams.

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 is a [type of person] with these qualifications.

Basic Qualifications:
  • Doctorate degree OR
  • Master's degree and 4 to 6 years of Quality experience OR
  • Bachelor's degree and 6 to 8 years of Quality experience OR
  • Diploma and 10 to 12 years of Quality experience

Preferred Qualifications:
  • Deep, broad knowledge of quality systems and processes, including change control, risk assessment, and risk management.
  • Quality and manufacturing experience in the biotechnology or medical device industry.
  • Familiarity with combination-product development, including characterization and method design.
  • Working knowledge of applicable combination-product regulations, guidance, and standards, including ISO 14971, ISO 13485, ISO 17025, ICH Q8/Q9/Q10/Q12, EU Annex 1, and 21 CFR Parts 4, 210, 211, and 820.
  • Familiarity with force-measurement equipment, dimensional analysis, calibration practices, and laboratory Good Laboratory Practices (GLP).
  • Experience providing quality oversight for device components.
  • Experience with quality processes and systems, such as TrackWise, Veeva, HLEE.
  • Demonstrated history of supporting or communicating during inspections and audits.
  • Strong problem-solving, troubleshooting, and analytical abilities.
  • Advanced technical-writing skills.
  • Ability to make constructive progress and drive outcomes amid uncertainty or ambiguity.
  • Ability to motivate change, improve efficiency, and build strong cross-functional relationships.
  • Demonstrated ability to lead continuous-improvement initiatives.
  • Ability to negotiate and build alignment after incorporating feedback from multiple stakeholders.
  • Experience driving decisions using DAI principles.
  • Strong understanding of industry expectations and regulatory requirements.
  • Effective collaboration and communication skills in global, cross-functional, highly matrixed organizations; able to balance divergent perspectives and drive issue resolution.
  • Bachelor's degree in a scientific discipline.


What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

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

careers.amgen.com

Salary Range
114,461.00USD -154,859.00 USD

About Amgen Inc

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. The company is values-based and deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious diseases. They offer products for treating illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.

Amgen Inc Careers

Join the dynamic team at Amgen Inc, a biotechnology pioneer dedicated to discovering, developing, and delivering innovative human therapeutics. At Amgen, we offer more than just job opportunities; we invite you to be part of a culture of leadership, diversity, and innovation.

Work You’ll Do

At Amgen Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that brings real solutions to patients worldwide. Our commitment to your career growth is evident in our professional development and leadership training programs designed to nurture your potential.

Innovate and Lead

Amgen Inc stands at the forefront of biotech innovation. Our team is constantly pushing the boundaries of science and technology. By joining us, you will contribute to a legacy of medical breakthroughs that improve the lives of millions.

Be Part of a Great Team

Amgen’s inclusive culture and commitment to diversity are integral to our success. We believe in empowering our employees with the skills and networking opportunities they need to thrive. Our team’s collaboration is the key to developing groundbreaking solutions.

Future-Proof Your Career

Amgen Inc offers a variety of career paths, from research and development to marketing and sales, providing near-limitless opportunities for advancement. Whether you are looking for a full-time position, an internship, or a leadership role, Amgen has a place for you. Our robust benefits package supports the well-being of our employees and their families, contributing to a fulfilling work-life balance.

Explore Job Opportunities

Discover the impact you can make with a career at Amgen Inc. We are hiring creative, curious, and motivated individuals ready to face challenges head-on. Explore our open positions that match your skills and interests.

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Join our team and stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await.

Interview and Resume Tips

Prepare for your future with Amgen Inc by utilizing our resources designed to enhance your interview skills and polish your resume. Our hiring process is designed to identify and attract professionals who are driven to make a difference.

Amgen Inc—Where Careers Grow

At Amgen Inc, we are committed to turning innovative science into value for patients. If you are passionate about joining a team that makes a difference, search Amgen jobs today and take the first step towards a fulfilling career.

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Join us at Amgen Inc, where your career can flourish in an environment of innovation, leadership, and growth.
Learn more about Amgen Inc
Size
24,200 employees
Market Cap
$141.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7.2 billion
Founded
1980
5 Year Trend
+2.5%
Revenue
$25.4 billion
NASDAQ
AMGN
* Ladders Estimates

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