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In this vital role, you will be part of Amgen India’s (AIN) Quality Control (QC) Technical Resources team, supporting Amgen’s global Quality Control network. The QC Technical Resources team will provide centralized document management expertise across global QC functions, ensuring the efficient, compliant, and consistent management of controlled documents within Amgen’s enterprise document management system. As a QC Specialist, you will be responsible for end-to-end document lifecycle management, including document creation, authorship, review, and revision, for a range of QC processes. These include, but are not limited to, general laboratory practices related to Cell Biology, Chemistry, Microbiology, Biochemistry, and Immunology, laboratory consumables and equipment management, and periodic trend assessments. This position offers a unique opportunity to collaborate with QC teams across Amgen sites worldwide, contributing to process harmonization and continuous improvement. You will gain broad exposure to Amgen’s diverse product portfolio and processes throughout the product lifecycle. This candidate will primarily work a shift-based schedule to enable the business in delivering Amgen’s mission to serve patients. The candidate may need to work outside of his/her routine workday to support business needs. The individual will be required to work from our office located in Hyderabad, India (Amgen India-AIN), and provide remote support from AIN to Amgen sites across multiple time zones globally.
Job Responsibility:
Managing document requests from the global QC Network, including intake, prioritization, and tracking to completion
Creating, authoring, revising, and coordinating workflows for a variety of controlled document types, ensuring completion within agreed timelines and in compliance with procedural requirements
Collecting, organizing, and analyzing data from multiple repositories (e.g., LIMS, electronic laboratory notebooks) to support document management activities
Facilitating information gathering and 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 assigned tasks and initiatives
Supporting issue identification and resolution, collaborating effectively across sites and functions to maintain operational continuity
Ensuring all controlled documents meet Amgen’s quality standards and comply with cGMP, safety, and other applicable regulatory requirements
Ensuring all assigned training requirements are completed, current, and compliant with cGMP standards
Identifying opportunities for continuous improvement to ensure alignment in document structure, formatting standards, and data retrieval/compilation practices across the network
Requirements:
Industry related experience related to one or more of the following: 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
Strong technical writing skills within a highly regulated environment
Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control
Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
Experience with various laboratory computer systems and applications
Nice to have:
Demonstrated innovative thinking and ability to transform work processes
Exposure to Operational Excellence initiatives
Understanding of Quality Control processes related to drug substance and drug product for clinical and commercial operations
Demonstrated ability to navigate through ambiguity and provide structured problem solving