Sr Associate QA

Senior Associate Quality Assurance Amgen Singapore Manufacturing HOW MIGHT YOU DEFY IMAGINATION?Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Senior Associate Quality Assurance in Amgen Singapore Manufacturing. Live What you will do Main Responsibilities Responsible for providing oversight for Quality on-the-floor and operations support, the Senior Associate QA will support Facilities & Engineering (F&E), Supply Chain Quality Control (QC), Technology, Process Development, Validation and all non-direct manufacturing across both ASM1 and ASM2. The areas of responsibility include oversight of day-to-day activities, deviations, CAPAs, Change Controls, projects, equipment and systems qualification. The role is a day shift role, but the team may be required to work rotating shift very occasionally (day/night) to support operations or project timelines. Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply. Support routine GMP documentation review activities (e.g. SOPs, logbooks, work orders, validation documents, periodic reviews) and ensure key performance indicator met targeted metrics Support the maturation and continuous improvement of Amgen quality systems, including on-the-floor quality oversight, deviations, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations Review and approve deviations, investigations, lab investigations, change controls, and other quality records (with focus on complex records). Participate in root cause investigations for deviations Support in regulatory inspections and interact directly with regulatory inspectors Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program and product quality review Win What we expect of you Basic Qualifications Master's degree OR Bachelor's degree and 2 years of directly related experience OR Associate degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience. Preferred 3 to 5 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems. Direct experience with bulk manufacturing of biopharmaceuticals/API preferred. Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well‐being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company. Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. #J-18808-Ljbffr