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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Senior Specialist-Manufacturing Investigations

Live

What you will do

Let’s do this. Let’s change the world. In this dynamic role you will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality, Process Engineering, Process Development, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs. Responsibilities include:

• Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process
• Present investigations to regulatory inspectors and internal auditors
• Clearly communicate investigation progress to impacted areas and leadership
• Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem-solving approach.
• Able to apply inductive and deductive reasoning in the investigation process
• Mentor and train other investigators in all aspect of their roles
• Develop and analyze Deviation metrics to support process improvement
• Clear and concise technical writing

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 2 years of Quality and/or Manufacturing experience OR Master’s degree and 6 years of Quality and/or Manufacturing experience OR Bachelor’s degree and 8 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 Quality and/or Manufacturing experience

Preferred Qualifications:

• 8+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
• Degree in Science or Engineering
• Experience leading complex investigations
• Experience using TrackWise for Deviation investigations and CAPAs
• Demonstrated project management ability
• Experience presenting to inspectors during regulatory inspections and internal audits.
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
• Strong interpersonal skills

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.

• Vast opportunities to learn and move up and across our global organization
• 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com