Sr Associate QA

5 days ago

Singapur, Singapore Amgen Full time

Senior Associate Quality Assurance – Amgen Singapore Manufacturing Amgen is a leading biotechnology company focusing on biopharmaceutical manufacturing. We are hiring a Senior Associate QA located in Singapore. Main Responsibilities Provide on‑the‑floor quality oversight and operations support to Facilities & Engineering, Supply Chain QC, Technology, Process Development, Validation and all non‑direct manufacturing across ASM1 and ASM2. Support day‑to‑day activities, deviations, CAPAs, change controls, projects, equipment and system qualifications. Review GMP documentation (SOPs, logbooks, work orders, validation documents, periodic reviews) and ensure key performance indicators meet targeted metrics. Participate in root‑cause investigations, support regulatory inspections, and interact directly with regulatory inspectors. Contribute to continuous improvement projects, supplier quality, stability program, and product quality reviews. Qualifications Master’s degree OR bachelor’s degree with 2 years of related experience OR associate degree with 4 years of relevant experience OR high school diploma/GED with 6 years of experience. 3–5 years of related work experience in manufacturing, process development or quality assurance in the pharmaceutical/biopharmaceutical industry, with increasing responsibility. Experience in bulk biopharmaceuticals/API manufacturing (preferred). Strong written and verbal communication skills, technical writing and presentation ability. Benefits Generous total rewards plan – health, financial and wealth, work/life balance, career benefits. Opportunities for learning and advancement across the global organization. Diverse and inclusive community of belonging. Your selection for this role will be subject to fulfilling the medical requirements of this job scope. Medical check(s) may be required; the company will cover related expenses. Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Individuals with disabilities are provided reasonable accommodation to participate in the application and interview process. #J-18808-Ljbffr

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