Career CategoryQualityJob DescriptionJoin Amgen's Mission to Serve PatientsIf you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnologycompanies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Sr Associate Quality Complaints Live What will you do?Amgen is seeking a Sr Associate Quality Complaints owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. The Sr. Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require escalation for further investigation. Evaluates and ensures triaged product complaint records comply with applicable proceduresEvaluates and owns complaint records with basic investigationsEnsures quality of complaint recordsCompletes assigned assessments per applicable proceduresApplies analytical skills to evaluate complex situations using multiple sources of information Executes the complaint process per SOP requirementsOwns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guideSupports management of assigned projects or project tasks to achieve agreed deliverables within time and with expected quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance Win What we expect of you?We are all different, yet we all use our unique contributions to serve patients. This role may require working in shifts or extended hours within the same shift. Basic Qualifications:Master’s degree ORBachelor’s degree and 2 years of Quality experienceOR Associate’s degree and 6 years of Quality experience OR High school diploma / GED and 8 years of Quality experience Fluency in verbal and written English to be able to understand & articulate technical concepts Preferred Qualifications:4+ years of quality and/or manufacturing experience in biotech, medical device or pharmaceutical industryBachelor’s Degree in a Science FieldLeadership skillsAbility to successfully manage workload to timelinesFamiliarity with basic project management toolsAbility to operate in a matrixed or team environment with site, functional, and senior management leadershipExperience in driving decision making by using the DAI principlesUnderstanding of quality and industry requirements/expectations of a QMSUnderstanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)Ability to negotiate a position after taking feedback from multiple sourcesDemonstrated ability to lead functional teams, consistently deliver on-time, and high-quality resultsAbility to translate business and stakeholder feedback and requirements into accurate and efficient processes using clear language and format.