Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our focus on four therapeutic areas -Oncology Inflammation General Medicine and Rare Disease- we reach millions of patients each year As a member of the Amgen team you ll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives Our award-winning culture is collaborative innovative and science based If you have a passion for challenges and the opportunities that lay within them you ll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career Position Summary The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network The Specialist QA will leverage industry technical and quality systems knowledge to provide support of product expiry management processes product complaints processes disposition manager training and fulfillment of disposition related data requests across the network The position will be responsible for tasks including the key responsibilities documented below and other disposition 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 DSI DS DP material shelf-life extension Executing the GMP process to extend expiration dates for clinical and commercial products produced at Amgen Updating batch product expiration dates in the Amgen SAP inventory management system Evaluating approve or reject expiry-SAF forms expiry stability assessment forms Disposition Support of Partner Requests Support requests made by Amgen partners for data and information related to their partnered product batches manufactured at Amgen sites Data recovery from systems including but not limited to manufacturing execution system electronic batch records the quality control laboratory information system the regulatory information management system and the Amgen enterprise resource management system SAP Uploading and communication of collected data to Amgen partners COA Generation special requests after disposition Generation and provision of Certificate of Analysis CofA records for Amgen drug substance drug product or final drug product batches Uploading and communication of collected documentation to requestor i e Amgen partners regulatory compliance to support RTQs process development Disposition Manager Training Execution and delivery of quality systems training to current disposition managers across the Amgen network via virtual meetings Training subject matter to include use of quality systems applied to execute the disposition process i e ERP SAP MES EBR ARRS LIMS TW CDOCS DQMS Kneat etc Maintenance and revision of training document materials in the controlled documents management system CDOCs Product Complaints Execution of the drug substance drug product and final drug product complaint full batch record review process Assessing electronic batch record EBRs documentation in the manufacturing execution system MES to identify any potential issues relevant to the complaint Recording the results of the complaints batch record assessment in the Bioconnect quality system Preferred Qualifications Experience in project management and related systems Proficiency in technical writing and data visualization tools experience with Smartsheet Tableau or equivalent platforms preferred Excellent verbal and written communication skills Proven ability to lead and collaborate within cross-functional teams in a dynamic fast-paced setting Experience in manufacturing environments Core Competencies Experience working in a regulated environment with knowledge of Good Manufacturing Practice GMP and Good Documentation Practice GDP requirements Experience working with Quality Systems that may include enterprise resource planning ERP SAP regulatory information management RIM controlled document management CDOCS change control QMTS deviation DQMS and quality control laboratory information management systems LIMS Experienced in staff training and development Technical Document Drafting and Workflow Ownership Basic Qualifications and Experience Master s degree with 8-12 years of Pharma and Biotech commercial or clinical manufacturing Quality experience