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.

SENIOR ASSOCIATE IQA (INCOMING QUALITY)

The new Amgen Advanced Assembly and Final Product Operation facility in Ohio is seeking a Senior Associate Quality Assurance for the incoming Quality team. The role will provide quality oversight for the GMP receiving area and be responsible for execution of raw material inspection, sampling, and disposition activities. The Incoming Quality Area is the area in the warehouse (owned by the QA team) where all materials needed for manufacturing of the finished drug product are sampled, inspected, and dispositioned before being used in any GMP operation. The incoming Quality team works closely with the supply chain planning organization and supplier quality management to ensure timely dispositioning of the raw materials that are required for finished drug product manufacturing at the facility. The Sr. Associate IQA will also provide support in ensuring compliant implementation of the quality management system within the incoming quality area and the warehouse area. This role will require local presence at the New Albany facility near Columbus, Ohio.

Live

What you will do

Let’s do this. Let’s change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

In this vital role you will be responsible for sampling, inspection and dispositioning all raw materials received at the facility under general supervision. A key aspect of this role is to apply critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include batch record review, SOP creation & review, documentation, review & approval of minor deviations and CAPA records and batch disposition of raw materials.

Responsibilities:

• Implement raw material sampling and inspection activities, including completion of GMP documentation to support raw material disposition

• Perform raw material disposition ensuring that all quality deliverables are met

• Provide quality expertise & guidance and work with operations partners, supply chain and supplier quality management to resolve issues and ensure timely release of the raw materials

• Own and review controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms

• Own, investigate and approve quality records including deviations/CAPAs assuring adherence to procedural requirements and confirming assessments and evaluations of different collaborators are complete and accurate as needed

• Find opportunities for continuous improvement and implement improvements in partnership with other operations teams

• Provide support during GMP Quality audits & inspections

• Support Lean Transformation and Operational Excellence initiatives

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with these qualifications.

Basic Qualifications:

Master’s degree

Or

Bachelor’s degree and 2 years of Quality and/or GMP Manufacturing experience

Or

Associate’s degree and 6 years of Quality and/or GMP Manufacturing experience

Or

High school diploma / GED and 8 years of Quality and/or GMP Manufacturing experience

Beyond that, additional preferred qualifications are:

• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies

• Experience in and knowledge of GMP/GCP operations or similarly regulated industry

• Affinity with digital innovation, data sciences and Quality engineering

• Experience with raw material receipt, inspection & sampling

• Highly effective verbal and written communication skills, strong interpersonal skills

• Great attention to detail and high degree of accuracy in GMP documentation

• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

• Strong organizational skills, including ability to follow assignments through to completion

• Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.

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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