Specialist Quality Control

You will play a crucial role as a QC Specialist within Amgen India's (AIN) Quality Control (QC) Technical Resources team, supporting Amgen's global Quality Control network. Your responsibilities will include end-to-end document lifecycle management, such as document creation, authorship, review, and revision for various QC processes like Cell Biology, Chemistry, Microbiology, Biochemistry, and Immunology. You will collaborate with QC teams across Amgen sites globally, contributing to process harmonization and continuous improvement while gaining exposure to Amgen's diverse product portfolio and processes throughout the product lifecycle. **Key Responsibilities:** - Managing document requests from the global QC Network, including intake, prioritization, and tracking to completion. - Creating, authoring, revising, and coordinating workflows for various controlled document types within agreed timelines and compliance requirements. - Collecting, organizing, and analyzing data to support document management activities. - Facilitating information alignment across the QC Network and cross-functional partners to support document updates and process harmonization. - Driving project deliverables to ensure timely and high-quality completion of tasks and initiatives. - Supporting issue identification and resolution across sites and functions to maintain operational continuity. - Ensuring all controlled documents meet quality standards and comply with cGMP, safety, and other regulatory requirements. - Identifying opportunities for continuous improvement in document structure, formatting standards, and data retrieval practices. **Basic Qualifications and Experience:** - Industry experience in Chemistry, Biochemistry, Cell Biology, Immunology, Microbiology, and Quality Control laboratory practices. - Educational qualifications ranging from a high school diploma/GED with 12 years of related experience to a Doctorate degree with 2 years of related experience. **Functional Skills:** **Must-Have Skills:** - Strong technical writing skills in a regulated environment. - Working knowledge of cGMP regulations and practices in Quality Control. - Excellent written and verbal communication skills, ability to work in a team environment, and build relationships. - Experience with laboratory computer systems and applications. **Good-to-Have Skills:** - Demonstrated innovative thinking and process transformation abilities. - Exposure to Operational Excellence initiatives. - Understanding of Quality Control processes in drug substance and drug product for clinical and commercial operations. - Ability to navigate ambiguity and provide structured problem-solving. (Note: No additional details about the company were included in the job description),