QA Analytical Specialist

QA Analytical Specialist

Sobi

Stockholm, Sweden

About the role

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.

Key Responsibilities

• Coordinator and Quality approver for deviations, CAPA and change controls.
• QA-approver for GMP-related analytical activities, e.g. validation and technology transfer of analytical methods used for in-process control, release and stability studies.
• Performance of quality evaluation of CLOs.
• QA contact for CLOs
• Provide Quality Assurance for stability studies for products where Sobi is the MAH, including approving plans and protocols.
• Perform QA review and approval of extension of expiry date of critical analytical material, including but not limited to reference standards and control samples.
• Perform QA review and approval of product specifications.
• Give support to Global Regulatory Affairs/CMC in analytical quality issues for variations and market expansions.
• Act as a representative of Global Quality and provide QA analytical guidance to support projects in order to ensure compliance with GMP
• Manage Quality Technical Agreements with CLOs.
• Author, review and approve SOPs and related documentation related to the position.

Qualifications

About you

You’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.

Qualifications

• University degree in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or similar.
• 5+ 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/similar).
• Broad knowledge of analytical chemistry and bioassays, including clear and compliant documentation practices.
• Professional proficiency in English, written and spoken.
• You live the Sobi CARE values: Care, Ambition, Urgency, Ownership and Partnership.
• Ability to work independently, take initiative, and make sound quality decisions.
• Strong communication skills and a collaborative, team-oriented approach.
• A structured mindset with attention to detail and a commitment to continuous improvement.