Sr. Associate QA - Warehouse Technical Operations (Tuesday - Saturday)

Career Category

Quality

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 QA - Warehouse Technical Operations

What you will do

Let’s do this. Let’s change the world. In this role as Senior Associate QA, you will be mainly responsible for providing QA guidance and support to AOH warehouse Operation and performing Quality Review of all inbound and outbound related documentation at AOH. Next to that, you will provide support in different QA related projects/systems. In this role, you will be in direct contact with a wide range of partners, and you will be accountable for establishing effective working relationships with warehouse supervisors and staff, Incoming QA and production leads, production and facilities and engineering.

The Sr. Associate QA for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Quality Assurance Floor Support team providing QA oversight to the warehouse operations. The Sr. QA Associate will support multiple warehouse functions (from the receiving of materials to the shipping of finished goods) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by using the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with Warehouse, IQA, and other groups, as needed. Advising staff on proper documentation as needed and performing other duties as assigned. This role will require local presence at the New Albany facility near Columbus, Ohio.

• Provide daily guidance and support to warehouse staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure regular presence in the warehouse area to provide oversight to GMP operations and quality systems.
• Act as a first point of contact in case of production warehouse staff inquiries (quality related) during operations.
• Lead, mentor, and coach personnel on quality matters, while driving the site Quality culture.
• Review and approve inbound and outbound processes and other GMP documentation in support of daily operations.
• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
• Review and approve Deviation, CAPA, and Change Control records.
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives.
• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting Environmental Health and Safety corporate and site goals

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

Basic Qualifications:

High school/GED + 4 years quality assurance work experience

Or

Associate’s + 2 years quality assurance work experience

OR

Bachelor’s + 6 months quality assurance work experience

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save tow