{"id":3709664,"url":"https://alion.io/job/alvotech-senior-specialist-quality-control","title":"Senior Specialist, Quality Control","company":{"id":2394553,"name":"Alvotech","domain":"alvotech.com","url":"https://alion.io/company/alvotech","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"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":["Reykjavík, Iceland"],"countries":["IS"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-03T22:24:18Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-06T07:19:40Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"The Quality Control department at Alvotech is looking for a dedicated and quality-minded senior specialist, with extensive experience in Analytical method technology transfers, CAPA management, Health Authority response, analytical investigations and scientific oversight.\nScope and responsibility:\nLead Analytical technology transfer activities between Alvotech and CMOs, ensuring successful method implementation and Lifecycle management of analytical methods.\nAct as the analytical subject matter expert for product testing methods, including chromatography, electrophoresis, compendial, and biochemical techniques.\nCoordinate transfer activities, troubleshoot technical challenges, and drive timely resolution of method-related issues.\nAuthor and Review transfer protocols, reports, validation\nundefined\nAuthor, review and approve CAPAs, change control, Document change controls, deviation investigation action and associated quality documentation. \nLead and support investigations related to analytical quality events, including invalid assays, OOS, OOT, and OOE results.\nLead the preparation of responses, scientific justifications for regulatory and Health Authority inquiries.\nCollaborate with ARD, Regulatory Affairs, Manufacturing, MSAT, and Quality Assurance teams to support product lifecycle management.\nDrive continuous improvement initiatives to enhance laboratory compliance, efficiency, and effectiveness.\nEnsure activities comply with cGMP requirements, internal procedures, and regulatory expectations.\nPerform training of other scientists in Analytical methods and related activities.\nCreates and updates documents for analytical methods\nJob requirements:\nBachelor’s or master’s degree in technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field)\n5-10 years of experience in Pharmaceutical or Biopharmaceutical industry.\nProven experience in analytical method technology transfer and product lifecycle management.\nStrong experience in managing CAPAs, Change Controls, Deviations, and complex analytical investigations.\nExperience supporting regulatory submissions and responding to Health Authority queries.\nExpert knowledge within field of expertise such as methods, techniques as well as relevant procedural/process knowledge\nOpen to flexible working hours.\nExcellent written and verbal communication skills.\nWhat we offer:\nAn inspiring challenge to work with great co-workers on ambitious projects that change people's lives.\nThe chance to be a part of a global and fast-growing company.\nAn international work culture that encourages diversity, collaboration and inclusion.\nPositive, flexible, and innovative work environment.\nSupport for personal growth and internal career development.\nCompany social events and milestone celebrations.\nExcellent in-house canteen and coffee house.\nExercise and wellbeing support for full-time employees.\nOn-site shower facility.\nTransportation grant towards eco-friendly modes of travel for full-time employees.\nInternet at home for full-time employees.","description_format":"text","description_chars":3041,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible 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