Senior Associate Quality Assurance

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 Singapore. Live What you will do Responsible for providing oversight for Quality on-the-floor and operations support, the Senior Associate Quality Assurance will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform 12-hour shift (day/night). Main Responsibilities 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 Independently complete routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports, deviation records and validation protocols etc.) and ensure key performance indicator met targeted metrics Support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations Act as Quality Assurance change control record assessor in change control activities and Quality Assurance contact for investigations. Participate in regulatory inspections, and interact directly with regulatory inspectors Coach site Quality Assurance professionals on resolution of routine operation issues Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. Win What we expect of you Basic Qualifications Masters Degree OR Bachelor’s Degree and 2 years of directly related experience OR Associate’s Degree and 4 years of directly related experience OR High School Diploma / GED and 6 years of directly related experience Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry Related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production Good communication skills (technical writing and verbal communication/presentation) and the ability to collaborate with stakeholders Interacts effectively with variety of communication and working styles Experience with regulatory audits and inspections Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality. Strong decision-making skills and ability to explain rationale to others Proactive in knowledge sharing with team members to help team enhance their skills 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