Senior Associate Quality Assurance

Overview Senior Associate Quality Assurance – Amgen Singapore Manufacturing How might you defy imagination? Amgen is a leading biotechnology company focused on bringing state-of-the-art medicines from laboratory to patient. JAPAC is the fastest growing region for Amgen. We are hiring a Senior Associate Quality Assurance in Singapore . Live What you will do Responsible for providing on-the-floor quality oversight and operations support. The Senior Associate Quality Assurance will support manufacturing operations and IPC testing through presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. This role requires a 12-hour shift (day/night). Responsibilities Provide Quality oversight to plant operations, ensuring GMP compliance and Amgen Quality Management System adherence through all phases from commissioning to market supply. Independently complete routine GMP documentation reviews (e.g., electronic batch records, SOPs, logbooks, work orders, batch production reports, deviation records, validation protocols) and achieve targeted KPI metrics. Support deployment of Amgen quality systems, including management review, validation, change control and CAPA, ensuring compliance with cGMP expectations. Act as Quality Assurance change control record assessor and serve as QA contact for investigations. Participate in regulatory inspections and interact directly with regulatory inspectors. Coach site Quality Assurance professionals on resolution of routine operation issues. Support other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, and customer complaint investigations. All listed tasks and responsibilities are deemed essential; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. What you can expect from us 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. Qualifications 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 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 a 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 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 the team enhance their skills Your selection Medical clearance may be required for this role. If applicable, you will be informed of the medical checks you may need to undergo. All medical-related expenses incurred will 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 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 reasonable accommodations to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation. #J-18808-Ljbffr