Amgen Inc. is hiring a Specialist Quality Control (Technical Resources)

Career Category Quality Role: In this pivotal position, you will be an integral member of Amgen India's (AIN) Quality Control (QC) Technical Resources team, providing critical support to Amgen's worldwide Quality Control network. The QC Technical Resources team will deliver centralized document management expertise across global QC functions, guaranteeing efficient, compliant, and uniform management of controlled documents within Amgen's enterprise document management system. As a QC Specialist, you will oversee comprehensive document lifecycle management, encompassing document creation, authorship, review, and modification, for various QC processes. These processes include, but are not limited to, fundamental laboratory practices related to Cell Biology, Chemistry, Microbiology, Biochemistry, and Immunology, laboratory consumable and equipment oversight, and periodic trend evaluations. This role presents a distinctive opportunity to engage with QC teams across Amgen sites globally, contributing to process standardization and ongoing enhancement. You will acquire extensive insight into Amgen's diverse product portfolio and processes throughout the product lifecycle. This candidate will primarily operate on a shift-based schedule to support the business in delivering Amgen's patient-focused mission. The candidate may be required to work beyond routine hours to meet business requirements. The individual will work from the Amgen India-AIN office in Hyderabad, India, and provide remote assistance to Amgen sites across multiple global time zones. Roles & Responsibilities: - Overseeing document requests from the global QC Network, including intake, prioritization, and tracking to completion - Developing, authoring, revising, and coordinating workflows for various controlled document types, ensuring timely completion and procedural compliance - Gathering, organizing, and analyzing data from multiple repositories to support document management activities - Facilitating information collection and alignment across the QC Network and cross-functional partners - Driving project deliverables to ensure timely and high-quality task completion - Supporting issue identification and resolution through cross-site and cross-functional collaboration - Ensuring controlled documents meet Amgen's quality standards and regulatory requirements - Maintaining completed training requirements in compliance with cGMP standards - Identifying continuous improvement opportunities for document structure and data practices Basic Qualifications and Experience: - Industry-related experience in Chemistry, Biochemistry, Cell Biology, Immunology, Microbiology - Quality Control laboratory experience - High school diploma / GED and 12 years of related experience OR - Associate's degree and 10 years of related experience OR - Bachelor's degree and 8 years of related experience OR - Master's degree and 6 years of related experience OR - Doctorate degree and 2 years of related experience Functional Skills: Must-Have Skills: - Advanced technical writing skills in a highly regulated environment - Comprehensive understanding of cGMP regulations and practices - Exceptional written and verbal communication abilities - Proficiency with laboratory computer systems and applications Good-to-Have Skills: - Demonstrated innovative thinking and process transformation capabilities - Exposure to Operational Excellence initiatives - Understanding of Quality Control processes for drug substance and product - Ability to navigate complexity and provide structured problem-solving approaches