Specialist Quality Control Support

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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Specialist Quality Control Support

What you will do

Let’s do this. Let’s change the world. In this vital role, you will lead a team responsible for QC Support. This group is responsible for Stability and Sample Management Teams. Responsibilities include the startup and validation of the laboratory electronic systems and equipment for the labs as well developing a complementary team of individuals. This role will support site start up and then transition to support of Amgen North Carolina commercial product release. The Specialist QC Support will report directly to the Director of Quality Control and as a member of this leadership team, you will contribute to encouraging and further developing the culture of Safety, Quality, and Lean Leadership.

• Responsible for QC Support laboratories establishment and routine operations.
• Responsible for Stability and Sample Management programs.
• Management of 3rd party shipments and contracts for testing.
• Ensure laboratories are operated in compliance with safety guidelines, cGLPs, cGMPs and other applicable regulatory requirements.
• Creation and approval of SOP’s, trend data, investigations, deviations, validation protocols, reports, method validation/verifications and equipment qualifications specific to QC support area.
• Participate in regulatory agency inspections and support site licensure.
• Establish and enable LEAN principles across all areas of responsibility.
• Establish and enable department goals, strategies and KPIs.
• Collaborate with management on significant matters, often requiring the coordination of activity across organizational units and exercise judgment independently.
• Translate sophisticated data into actionable information and apply strong technical knowledge to meet business objectives.
• Identify process gaps, introduce innovative solutions, and lead operational excellence projects within the Amgen global QC network to improve efficiency and productivity, while decreasing expense/operating costs.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a dynamic team player with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality Control experience OR
• Associate’s degree and 8 years of Quality Control experience OR
• Bachelor’s degree and 4 years of Quality Control experience OR
• Master’s degree and 2 years of Quality Control experience OR
• Doctorate degree

Preferred Qualifications:

• Degree in Scientific Field such as Molecular Biology, Biochemistry or Pharmaceutical Sciences.
• Previous experience in Qualification and Validation of Equipment and test methods.
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your specialist experience may run concurrently with the required technical experience referenced above.
• Able to drive process improvement within area of responsibility.
• Able to successfully manage multiple workstreams to timelines.<