Specialist- Manufacturing Investigations

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.

Specialist-Manufacturing Investigations

Live

What you will do

Let’s do this. Let’s change the world. In this dynamic role you will be a member of the team that investigates Deviations in the Amgen Thousand Oaks Development Supply Chain Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, and Warehouse Operations. 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
• 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 OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree or & 5 years of directly related experience OR Associate’s degree & 10 years of directly-related experience OR High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:

• 5 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

Some of the vast rewards of working here

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.

• 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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