Senior Associate Quality Systems - Warehouse

Career Category

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.

Sr. Associate Warehouse Quality Systems

What you will do

Let’s do this! Let’s change the world!

In this vital role you will be part of the Supply Chain team, and you will participate in multiple cross-functional initiatives for Amgen North Carolina (ANC) warehouse. You will serve as warehouse Subject Matter Expert and as site representative on various cross-functional task forces and teams to ensure that consistent and well-integrated practices are developed throughout the organization. The focus of the Sr. Associate is to own and manage warehouse quality systems records, including deviations, change control records, CAPA records, documentation and training, as well as supporting operational readiness and inspection readiness activities.

• Lead triage meetings

• Own quality systems records, such as deviations, change control records and CAPA records.

• Track and manage timely closure of quality records. Timely escalate issues to prevent impact to timelines.

• Become an SME on quality systems related to the warehouse.

• Represent ANC Supply Chain in interdisciplinary system-related projects/initiatives and possibly lead work streams within such projects (e.g., investigations and CAPA agreements)

• Identify and manage warehouse risks.

• Lead inspection readiness initiatives for the warehouse.

• Own relevant Supply Chain procedures and conduct required periodic reviews

• Establish relationships with key stakeholders across multiple functional areas, both onsite and virtually.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong strategic problem solver with these qualifications.

Basic Qualifications:

• High school diploma/GED and 4 years of operations, business, or supply chain experience OR

• Associates Degree and 2 years of operations, business, or supply chain experience OR

• Bachelor’s degree and 6 months of operations, business, or supply chain experience OR

• Master’s degree

Preferred Qualifications:

• Technical Writing skills - Preferred experience writing and owning deviation records and procedures.

• Experience conducting Investigations and root cause analysis, Process Improvement with a Continuous improvement mentality.

• Experience supporting Compliance inspections in GMP environments.

• Supply Chain & Logistics Management, Science or Engineering educational background.

• Supply Chain experience with a focus on warehouse operations and systems

• Knowledge of Supply Chain processes, and Operational Excellence

• Basic knowledge of ERP (SAP) and SAP Warehouse Management (WM)

• Good understanding of Warehouse Master Data in SAP

• Good understanding of current Good Manufacturing/Distribution Practices

• Quick process understanding, insight and visualizing

• Experience in managing projects or work streams (cross functional)

• Availability to support non-standard shift organization with the flexibility to work extended hours.

• Good organizational and negotiation skills

• Experience working in a global environment, ability to collaborate closely/communicate effectively at different management levels.

• Proficient user of software applications (Excel, PowerPoint, Smartsheet, Skype, Tableau).

What you can expect of us

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