{"id":2690804,"url":"https://alion.io/job/amgen-it-quality-specialist","title":"IT Quality-Specialist","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":"B","score":79,"open_postings":437,"ghost_share":0.002,"stale_share":0.831,"repost_share":0.007,"time_to_fill_p50_days":27,"computed_at":"2026-10-17T05:46:00Z"}},"role":"Support","role_family":"Support","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":18500,"max_usd":46000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":61},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"ServiceNow","optional":false},{"name":"Confluence","optional":true},{"name":"GCP","optional":true},{"name":"Jira","optional":true},{"name":"Power BI","optional":true},{"name":"Smartsheet","optional":true}],"status":"live","first_seen_at":"2026-10-16T08:54:53Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-18T01:17:32Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Career Category\nQualityJob Description\nJob Description\nJoin Amgen’s Mission of Serving Patients\nAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.\nSince 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.\nOur award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.\nWhat you will do\nLet’s do this. Let’s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.\nThis individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.\nResponsibilities\nReview validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for Minor and Major Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections.\nValidation\nDemonstrated expertise in risk-based validation (RBV) methodologies, providing execution and guidance to cross-functional teams on complex GxP projects while ensuring alignment with Computer Software Assurance (CSA) principles.\n\nProven ability to serve as the QA point of contact for assigned GxP systems, ensuring timely review and approval of documentation in compliance with Amgen’s standard operating procedures and applicable regulatory standards.\n\nChange Control Management: Drive Change Request (CR) and Change Control processes, from initiation through approval, ensuring accurate system impact assessment and documentation. (e.g Trackwise/Veeva , ServiceNow)\n\nValidation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards.\n\nRequirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices.\n\nSystem Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production.\n\nData Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards.\n\nPeriodic Review/Audit Trail\nSystem Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance.\n\nSupplier Management\nSupplier Evaluations: Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards.\n\nDeviation & CAPA Management:\nInitiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution.\n\nAct as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards.\n\nCAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution.\n\nResponsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives.\nReview and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards.\nApply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions.\nContributes to continuous improvement efforts and initiatives.\nAssists with training initiatives and strategy as required.\nProvides support for the Management Review Process when needed.\nSupports the Integrated Systems Assessment (ISA) Process as necessary.\nParticipates in and aids with regulatory inspections as required.\nThe individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy.\nWhat we expect from you\nWe are all different, yet we all use our unique contributions to serve patients.\nBasic Qualifications:\nMaster’s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR\n\nBachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience\n\nPreferred Qualifications:\nStrong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards.\n\nProven experience in the validation of computerized systems (GxP).\n\nStrong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP).\n\nExperience managing quality assurance processes, including Major and Minor Deviations.\n\nDemonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills.\n\nStrong decision-making abilities with the capacity to drive tasks to completion.\n\nAbility to work independently with minimal supervision.\n\nLeadership skills with experience leading projects, teams, or tasks.\n\nExperience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo.\n\nBroad technical expertise within specialty area and familiarity with industry standards.\n\nAbility to provide training, guidance, and contribute to team quality.\n\nWorks closely with senior staff and external experts to extend capabilities and enhance performance.\n\nData analysis skills (Good to have)-\nPerform data analysis to create impactful visuals and dashboards for informed decision-making.\n\nDesign clear, engaging charts and graphics for presentations and reports.\n\nUtilize tools like Power BI, Smartsheet, or similar to develop interactive, data-driven visuals.\n\nTranslate complex data into concise, compelling visual stories for diverse audiences.\n\nCollaborate with cross-functional teams to align visual outputs with business goals.\n\nWhat you can expect of us\nAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.\nIn addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.\nApply now\nfor a career that defies imagination\nObjects in your future are closer than they appear. Join us.\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 to 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 with 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 accommodation.\n.","description_format":"text","description_chars":9327,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-16T08:54:53Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":0,"expected_fill_days":27,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-17T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/amgen-it-quality-specialist","json_url":"https://alion.io/job/amgen-it-quality-specialist.json","meta":{"generated_at":"2026-10-18T12:39:45Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":18703,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-19T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-it-quality-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Famgen-it-quality-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Famgen-it-quality-specialist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/amgen-it-quality-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-it-quality-specialist"}]}