QA Specialist - Digital QA/IS Validation

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. 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. 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 leading and guiding cross functional staff, under general supervision, as an informed Subject Matter Expert in the Digital Quality space related to computer systems validation and electronic records compliance. A key aspect of this role is to apply problem solving skills to ensure quality and compliance to ALCOA++ and GMP regulations for all area operations and associated processes. You will provide Quality oversight of the development and implementation of the digital advancement opportunities for the facility and will lead the digital Quality strategy for the facility. 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 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: Doctorate degree OR Master’s degree and 2 years of Quality and/or Manufacturing experience Or Bachelor’s degree and 4 years of Quality and/or Manufacturing experience Or Associate’s degree and 8 years of Quality and/or Manufacturing experience Or High school diploma / GED and 10 years of Quality and/or Manufacturing experience Preferred 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, ICHs, 21 CFR Part 11, EU Annex 11 and similarly regulated industry Affinity with digital innovation, data sciences and Quality engineering Computer systems validation knowledge and experience with Automated Systems, Electronic Batch Record, Electronic Quality Management System, IIOT, Digital Control Tower, Advanced Analytics. etc. Proficiency with Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe Acrobat; database related platforms; knowledge of Trackwise, PAS-X, Vault Quality Docs, SAP, LIMS etc. Experience in review/approval validation documentation Skilled in technical writing and critical reasoning Excellent written and verbal communication skills, ability to work in a team matrix environment and establish relationships with partners Great attention to detail and high degree of accuracy in task fulfillment and GMP documentation Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations Experience working with dynamic cross-functional teams and demonstrate abilities in decision making Strong organizational skills, including ability to follow assignments through to completion Strong leadership capabilities and experience applying GMP requirements in an operational setting Ability to independently interact with various levels, drives tasks to completion, and is a self-starter. 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