{"id":3054585,"url":"https://alion.io/job/amgen-specialist-quality-assurance-technical-support","title":"Specialist Quality Assurance (Technical Support)","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":357,"ghost_share":0,"stale_share":0.577,"repost_share":0.003,"time_to_fill_p50_days":42,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Singapore"],"countries":["SG"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":45000,"max_usd":90000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":377},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-22T03:13:37Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-29T06:26:28Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"Career Category\nQualityJob Description\nJoin Amgen's Mission to Serve Patients\nAt Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.\nAmgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.\nIf you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.\nSpecialist Quality Assurance I\nWhat you will do\nResponsible for providing oversight and leadership for quality systems execution and operations support, the Specialist Quality Assurance will support Facilities & Engineering (F&E), Quality Control (QC), Technology, Process Development (PD) or Validation (all non-direct manufacturing areas) for the Biologics and Synthetic Manufacturing plants.\nMain Responsibilities:\nProvide 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 and qualification, regulatory approval and market supply\nSupport routine GMP documentation review activities (e.g. SOPs, logbooks, work orders, validation documents, periodic reviews) and ensure key performance indicator met targeted metrics\nCo-lead and support the deployment of Amgen quality systems, including management review, validation, deviation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations\nReview and approve deviations, investigations, testing result investigations, change controls, and other quality records (with focus on highly complex records). Participate in and lead complex root cause investigations for deviations\nLead Quality Assurance oversight in commissioning and qualification projects or New Product Introduction (NPI)\nCoach site Quality Assurance professionals on resolution of quality issues\nParticipate in regulatory inspections and interact directly with regulatory inspectors\nLead or support function/site/network initiatives and continuous improvement projects\nWhat we expect of you\nDoctorate Degree\nMaster’s degree and 2 years of experience in pharmaceutical company or GMP environment OR\nBachelor’s degree and 4 years of experience in pharmaceutical company or GMP environment OR\nDiploma and 8 years of experience in pharmaceutical company or GMP environment\nPreferred 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.\nDirect experience with bulk manufacturing of biopharmaceuticals/API preferred.\nDemonstrated 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. People and stakeholder management.\nExperience with regulatory audits and inspections· \nProblem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.\nYour 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.\nWhat you can expect of us\nAs we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.\nApply now and help transform the lives of patients while transforming your career.\ncareers.amgen.com\nAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease.\nAmgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.\nWe will ensure that individuals with disabilities are provided 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. 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