QA Analytical Specialist

ph3Company Description /h3 pAt Sobi, the work we do every day redefines the standards of care and transforms the lives of people living with rare diseases. We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development. /p h3Job Description /h3 pGlobal Quality plays a key role in ensuring our medicines meet internal standards, regulatory expectations, and the commitments in our registration files. As an independent quality organisation, we deliver on these commitments while strengthening our capabilities. As QA Analytical Specialist, you’ll be the quality partner for analytical activities and stability studies for products where Sobi is the MAH. You’ll ensure GMP‑compliant methods and data support reliable release and stability testing for both clinical and commercial supply—working closely with internal stakeholders and external partners to keep quality, compliance, and patient impact at the centre of everything we do. It is a hybrid role and can be based in either Stockholm or Basel, reporting to Head of Quality Product Lifecycle Clinical Supply. /p h3Key Responsibilities /h3 ul liCoordinator and quality approver for deviations, CAPA and change controls. /li liQA‑approver for GMP‑related analytical activities, e.g. validation and technology transfer of analytical methods used for in‑process control, release and stability studies. /li liPerformance of quality evaluation of CLOs. /li liQA contact for CLOs. /li liProvide quality assurance for stability studies for products where Sobi is the MAH, including approving plans and protocols. /li liPerform QA review and approval of extension of expiry date of critical analytical material, including reference standards and control samples. /li liPerform QA review and approval of product specifications. /li liGive support to Global Regulatory Affairs / CMC in analytical quality issues for variations and market expansions. /li liAct as a representative of Global Quality and provide QA analytical guidance to support projects to ensure compliance with GMP. /li liManage quality technical agreements with CLOs. /li liAuthor, review and approve SOPs and related documentation related to the position. /li /ul h3Qualifications /h3 pYou’re a quality‑minded analytical professional who enjoys working cross‑functionally, taking ownership, and bringing structure to complex scientific work. You combine strong GMP understanding with a collaborative mindset, and you’re motivated by the opportunity to help deliver reliable, high‑quality medicines to patients who need them most. /p ul liUniversity degree in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or similar. /li li5+ years’ experience in GMP analytical work within pharma/biotech—covering analytical method development and validation, product specifications, deviation investigations, and change control; ideally in QA supporting QC (or as a QC Coordinator or similar). /li liBroad knowledge of analytical chemistry and bioassays, including clear and compliant documentation practices. /li liProfessional proficiency in English, written and spoken. /li liYou live the Sobi CARE values: Care, Ambition, Urgency, Ownership and Partnership. /li liAbility to work independently, take initiative, and make sound quality decisions. /li liStrong communication skills and a collaborative, team‑oriented approach. /li liA structured mindset with attention to detail and a commitment to continuous improvement. /li /ul h3Benefits /h3 ul liCollaborative and team‑oriented environment. /li liOpportunities for professional growth. /li liDiversity and inclusion. /li liCompetitive compensation. /li liPositive impact on ultra‑rare disease patients. /li liEmphasis on work/life balance. /li /ul /p #J-18808-Ljbffr