QA Specialist - Digital QA/IS Validation

About the role

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Quality Assurance Specialist Reporting to the Senior Manager Quality, the QA specialist for the Amgen Advanced Assembly and Final Product Operations facility will provide quality oversight support of the design, installation, commissioning & qualification of business software applications and automated systems. This can cover a wide range of quality processes that drive and govern operations in manufacturing, warehousing and quality assurance for the local site and the Amgen network. The QA specialist will also provide quality oversight for the manufacturing and warehouse digital operations. This role will require local presence at the New Albany facility near Columbus, Ohio.

Responsibilities

• Provides quality and compliance expertise & guidance and agrees on implementation strategies related to the design, installation, commissioning & qualification, and process qualification of the digital manufacturing strategies for the facility.
• Identify digital advancement opportunities for quality and lead their implementation into the facility while ensuring Quality Processes are adhered to or adjusted as appropriate.
• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure digital advancement is implemented in accordance with established procedures and applicable regulations.
• Partner with other facilities in the network to ensure implementation of digital solutions and standard processes, consistency, and continuous improvement.
• Reviews and approves controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports.
• Ensures that all activities & related documentation comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Data Integrity, Safety, and Controls.
• Own quality related Standard Operating Procedures, Work Instructions, Forms.
• Ensure relevant processes, equipment, system are validated and the validation is current.
• Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Support Lean Transformation and Operational Excellence initiatives.

Requirements

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

Qualifications

• Master’s or Bachelor’s Degree in Science, Computer Science, Engineering
• Educated in a science, computer science, engineering field with 5 years of experience in GMP operations,