Sr Associate Quality Control

As a QC Senior Associate at Amgen India (AIN), you will play a crucial role in supporting Amgen's global Quality Control network. Your responsibilities will involve managing end-to-end document lifecycle, collaborating with QC teams worldwide, and contributing to process harmonization and continuous improvement. You will primarily work a shift-based schedule to support Amgen's mission of serving patients, with the flexibility to work outside routine hours if needed. Your base of operation will be Amgen India-AIN in Hyderabad, India. **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, meeting agreed timelines and procedural requirements. - Collecting, organizing, and analyzing data from multiple repositories to support document management activities. - Facilitating information gathering and alignment across the QC Network and cross-functional partners for 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 for operational continuity. - Ensuring completion of all assigned training requirements and compliance with cGMP standards. - Ensuring all controlled documents meet Amgen's quality standards and regulatory requirements. - Identifying opportunities for continuous improvement in document structure, formatting standards, and data retrieval practices across the network. **Qualifications Required:** - Industry-related Microbiology and/or Environmental Monitoring experience. - Quality Control laboratory experience. - Degree in Microbiology or other Life Science. - High school diploma / GED and 12 years of related experience OR - Associates degree and 10 years of related experience OR - Bachelors degree and 8 years of related experience OR - Masters degree and 6 years of related experience OR - Doctorate degree and 2 years of related experience. In addition to the above qualifications, you must have: - Technical writing experience. - Excellent written and verbal communication skills to work effectively in a team matrix environment and build relationships with partners. - Experience with various laboratory computer systems and applications. **Good-to-Have Skills:** - 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. - Strong collaboration skills across functions.,