Specialist QA

Role Overview: As an AIN Specialist QA at Amgen, you play a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. Your responsibilities include leveraging industry, technical, and quality systems knowledge to provide support for product expiry management processes, product complaints processes, disposition manager training, and fulfilling disposition related data requests across the network. You will primarily work during regular working hours to enable the business in delivering Amgen's mission to serve patients and may lead a shift-based team providing coverage across multiple time zones. Your role is essential in ensuring the quality and compliance of Amgen's products, ultimately impacting the lives of patients. Key Responsibilities: - DSI/DS/DP material shelf-life extension - Execute the GMP process to extend expiration dates for clinical and commercial products. - Update batch product expiration dates in the Amgen SAP inventory management system. - Evaluate (approve or reject) expiry-SAF forms. - Disposition Support of Partner Requests - Support requests from Amgen partners for data and information related to partnered product batches. - Recover data from systems like manufacturing execution system electronic batch records, quality control laboratory information system, etc. - Upload and communicate collected data to Amgen partners. - COA Generation, special requests after disposition - Generate and provide Certificate of Analysis (CofA) records for Amgen product batches. - Upload and communicate collected documentation to requestors. - Disposition Manager Training - Execute and deliver quality systems training to new disposition managers across the network. - Train on the use of quality systems for the disposition process. - Maintain and revise training document materials in the controlled documents management system. - Product Complaints - Execute the batch record review process for drug substance, drug product, and final drug product complaints. - Assess electronic batch record documentation to identify potential issues. - Record results of complaints batch record assessment in the Bioconnect quality system. Qualification Required: - Preferred Qualifications - Experience in project management and related systems. - Proficiency in technical writing and data visualization tools. - Excellent verbal and written communication skills. - Ability to lead and collaborate within cross-functional teams. - Experience in manufacturing environments. - Core Competencies - Experience in a regulated environment with knowledge of GMP and GDP requirements. - Familiarity with Quality Systems like ERP/SAP, RIM, CDOCS, QMTS, DQMS, LIMS. - Experience in staff training and development. - Technical Document Drafting and Workflow Ownership. - Basic Qualifications and Experience - Masters degree with 8-12 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.,