Senior Associate IQA First Shift Tuesday thru Saturday

Career Category

Quality

Job Description

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

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

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:

High school/GED + 4 years of Quality and/or GMP Manufacturing experience

OR

Associate’s + 2 years of Quality and/or GMP Manufacturing experience

OR

Bachelor’s + 6 months years of Quality and/or GMP Manufacturing experience

OR

Master's

Preferred Qualifications:

• Scientific degree in Life Sciences, Physi