QA Specialist - Digital QA/IS Validation

Role: Quality Assurance Specialist responsible for overseeing digital quality systems and compliance at Amgen’s Advanced Assembly and Final Product Operations facility in New Albany, Ohio. Objectives include guiding the design, installation, commissioning, qualification, and continuous improvement of manufacturing and warehouse digital systems, ensuring adherence to GMP, ALCOA++, and data integrity standards. Responsibilities encompass providing quality oversight for software validation, electronic records, and digital initiatives; collaborating across functions and network facilities to standardize digital processes; reviewing validation documentation; supporting regulatory audits; and driving digital quality strategies. Qualifications: Doctorate or Master’s in Science, Engineering, or related field with 2+ years of Quality or manufacturing experience; or Bachelor’s with 4+ years, or equivalent experience. Preferred skills include GMP operations, computer systems validation, familiarity with platforms like Trackwise, SAP, LIMS, and data sciences, along with strong technical writing, communication, leadership, and problem-solving abilities. High-value specifics involve GMP-compliant digital manufacturing, validation, electronic batch records, and data integrity in biologics or pharmaceutical manufacturing. The role requires local presence in Ohio with no specified travel expectations.