Specialist QA

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.

Specialist QA

Live

What you will do

Let's do this. Let's change the world. In this vital role you will contribute to our B7 QA team supporting EPO manufacturing with responsibilities of ensuring the quality and compliance of the medicine we manufacture.

Responsibilities:

• Perform all activities in compliance with Amgen safety standards, SOP's and Quality System Requirements
• Serve as an individual contributor and collaborate with the team of B7 QA professionals to ensure Amgen's quality requirements are met
• Contribute as the quality contact on root cause analysis, identification and implementation of corrective and preventive actions for quality issues and deviations
• Review and approve quality documents, such as protocols, reports, SOPs, change controls, deviations, CAPAs, and OOS investigations
• Collaborate with cross-functional teams, such as Manufacturing, Engineering, Validation, and Regulatory Affairs, to ensure quality alignment and support
• Actively Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control, Self-Inspection and Investigations) and provide active input into shaping the future direction of these systems
• Lead or participate in internal and external audits and inspections, as well as vendor qualification and oversight

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master's degree and 2 years of quality assurance or quality control in the biotechnology or pharmaceutical experience

Or

Bachelor's degree and 4 years of quality assurance or quality control in the biotechnology or pharmaceutical experience

Or

Associate's degree and 8 years of quality assurance or quality control in the biotechnology or pharmaceutical experience

Or

High school diploma / GED and 10 years of quality assurance or quality control in the biotechnology or pharmaceutical experience

Preferred Qualifications:

• A bachelor's degree or higher in Engineering, Science, or a related field
• At least 5 years of experience in quality assurance or quality control in the biotechnology or pharmaceutical industry
• Experience in biologics production, testing, and release
• Knowledge of cGMPs, ICH guidelines, ISO standards, and other relevant regulations
• Strong leadership, communication, problem-solving, and analytical skills
• Proficiency in Microsoft Office and other quality software tools

Thrive

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

Apply now

for a career that defies imagination

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

Application deadline

External/Internal postings:

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.