QA Technical Senior Associate

2 weeks ago

Hyderabad India Amgen Full time

Job Description Job Description The QA Technical Senior Associate supports Quality Assurance initiatives across the Quality Operations Network with a primary focus on Technical Writing, Document Management, and Business Performance. This role is responsible for executing key QA documentation processes, system coordination, and project-related administrative functions to ensure compliance with Quality Management System (QMS) expectations and operational efficiency. The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgen's mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally. Key Responsibilities Technical Writing and Document Management - Manage requests for site licenses and country-specific reports, such as regulatory memo requests. - Draft and manage workflows for QA-owned procedures, including Standard Operating Procedures (SOPs) and Appendices (APPX). - Conduct periodic document reviews and support authoring and workflow coordination as required. - Provide document system support using tools such as DocuSign and Kneat. Business Performance - Create and maintain Smartsheet trackers and dashboards to support quality and business operations. - Provide project coordination and administrative support for activities including invoicing, expense reporting, audit logistics, poster/presentation compilation, and travel arrangements. Preferred Qualifications - Experience in a GMP or regulated environment with exposure to quality documentation systems and tools. - Strong attention to detail with demonstrated capability in document drafting and editing. - Proficiency in document and project management systems such as DocuSign, Kneat, and Smartsheet. - Effective organizational and time management skills with ability to manage multiple priorities. - Strong communication and interpersonal skills for cross-functional coordination. - Ability to follow established procedures and work independently within defined parameters. Core Competencies - Technical Writing and Document Control - System and Workflow Coordination - Business Operations and Project Support - Cross-Functional Communication and Collaboration - Organizational Agility - Detail-Oriented Execution Basic Qualifications And Experience - Master's degree with 6 to 8 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

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