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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.

Manufacturing Specialist

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will report into the Senior Manager of the Investigation and Training team and interacts broadly across the site to implement key business results, quality initiatives, and continuous improvement projects within the AR5 and AR30 plants. This role will focus on supporting manufacturing training, and supporting the site major investigations. The flexibility to support all four shifts covering 24/7 operations is a requirement. The successful candidate will conduct technical investigations for our clinical and commercial Drug Substance Operations and is responsible to understand the investigation process as well as the manufacturing processes for the Amgen Rhode Island Facility. In this role, the Mfg. Specialist will maintain close interactions with the Manufacturing leads, Engineering, Process Development, Quality Controls, Supply Chain, and Quality functions to mitigate product impact and supply to product/process improvement. .

• Be able to perform major investigations record at the site – Leading meetings, sending minutes, RCA, identification of CAPA, and development of a deviation report.
• Supporting Training improvements across both manufacturing plants
• Support the training Center (Material availability, training coordination, housekeeping and area safety)
• Support the development and execution of the cross-training strategy and Rapid onboarding
• Providing training expertise for area of responsibility
• Be able to support the investigation team
• Trouble shooting and problem-solving support to manufacturing
• Identifying and autonomously implementing continuous improvement opportunities
• Owning and implementing corrective/preventative actions
• Supporting Manufacturing specialists during complex investigations and change controls
• Owning and authoring SOPs
• Providing data to support management evaluation of performance trends
• Applies knowledge and subject matter expertise to ensure end-to-end of investigations
• Lead discussion to reduce, correct, mitigate and prevent the reoccurrence of the event based on output of root cause analysis.
• Perform trend investigations, including statistical assessment of data to identify trends, as well as generation of reports.
• Perform notification of potential product impact.
• Advise management on investigation progress, product/ process risk, and potential delays.
• Support functional management initiatives and objectives
• Anticipates and prevents potential issues with regulators
• Own and/or Drive Improvement projects/initiatives
• Collaborate cross functionally as needed to ensure the Quality Management System processes are performed in accordance with established procedures.
• Alert senior management of quality, compliance, supply and safety risks.

Win

What we expect of you

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

• Doctorate degree OR
• Master’s degree and 3 years of Manufacturing and Operations experience OR
• Bachelor’s degree and 5 years of Manufacturing and Operations experience OR
• Associate’s degree and 10 years of Manufacturing and Operations experience OR
• High school diploma / GED and 12 years of Manufacturing and Operations experience

Preferred Qualifications

• 5+ years of demonstrated ability in investigation process.
• Strong technical writing
• Proven Six Sigma proficiency specifically for root cause analysis methodology
• Understanding and application of Drug Substance process, data mining, quality and compliance.
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Project Management experience
• Able to influence tri-functional team and organizational leads
• Familiarity with the training development and facilitation
• Experience owning and editing standard operating procedure

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we 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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