Quality Assurance Job at Alvotech, Iceland | Life Sciences | Apply Now
If you are an experienced microbiologist, a meticulous cleanroom data analyst, or a biotechnology professional looking to transition your laboratory testing insights into global regulatory compliance, this full-time role at Alvotech is an exceptional opportunity. Located at our world-class global headquarters in Reykjavik, Iceland, this position puts you on the frontline of batch release operations, environmental monitoring governance, and cGMP compliance. For detail-oriented compliance experts searching for a high-value Quality Assurance Job, this role offers hands-on mastery over electronic data systems like MODA, LIMS, and Veeva Vault. It serves as an elite operational launchpad to build a long-term Alvotech career and stands out as a premier choices for anyone looking to secure a high-prestige Life Sciences Job within Europe’s rapidly advancing biopharmaceutical sector.
- Job Position: QA Specialist
- Location: Reykjavik Headquarters
- Job requisition ID: JR100372
About The Company
Alvotech is a global biopharmaceutical powerhouse dedicated exclusively to the development and commercial manufacture of high-quality biosimilar medicines for patients worldwide. By leveraging a fully integrated, state-of-the-art R&D and manufacturing hub, Alvotech accelerates the global availability of cost-effective biologic therapies, targeting complex therapeutic areas such as autoimmunity, oncology, and inflammatory conditions. The striking global headquarters in Reykjavik, Iceland, operates as a highly automated facility featuring advanced single-use bioreactor systems and an integrated digital quality architecture. Joining the Quality Assurance (QA) team means working alongside an international cohort of scientists, engineers, and regulatory specialists. Within this fast-growing company culture, your daily documentation audits and quality oversight serve as the final checkpoint guaranteeing that commercial drug batches are uncompromised and fully inspection-ready.
Quality Assurance Job – Key Responsibilities
The QA Specialist functions as a critical compliance engine, executing thorough technical reviews of micro-validation files and authorizing documentation packages required for batch release.
Your core batch audit, documentation control, and quality mitigation duties include:
- Microbiology & QC Batch Auditing: Reviewing, verifying, and approving complex microbiology and Quality Control batch documentation to ensure complete compliance with current Good Manufacturing Practice (cGMP) standards.
- Electronic Data Review Management: Supporting multi-market batch release activities by auditing automated data entries, testing logs, and chain-of-custody files within MODA, LIMS, and related enterprise software portals to advance this Quality Assurance Job.
- Environmental Monitoring Reporting: Compiling, analyzing, and generating formal Environmental Monitoring (EM) batch summary reports, evaluating cleanroom particle and microbial thresholds.
- Document Control & Archiving Architecture: Managing rigorous document control, technical filing, and long-term compliance archiving activities according to standard operating procedures (SOPs).
- Veeva SOP Governance: Preparing, revising, technically reviewing, and approving SOPs and controlled site documents utilizing the cloud-based quality platform Veeva.
- Quality Event Closure Verification: Verifying that all deviations, Quality Events, Corrective and Preventive Actions (CAPAs), and Change Controls are fully completed and legally closed out before finalizing batch documentation to support your Alvotech career.
- KPI Metrics Tracking: Monitoring and tracking departmental Key Performance Indicators (KPIs) and escalating critical documentation discrepancies or testing delays to QA leadership.
- Inspection Readiness Maintenance: Participating in cross-functional preparation blocks to ensure the facility remains continuously ready for external client audits and global regulatory inspections (e.g., FDA, EMA).
Qualifications & Profile Requirements For Quality Assurance Job
Alvotech seeks a systematic, detail-oriented quality professional who demonstrates a proactive approach to risk management and thrives within an international, cross-functional team matrix.
- Required Academic Standards:
- Educational Foundation: A completed formal Bachelor of Science (BSc) degree in Microbiology, Life Sciences, Biotechnology, or a closely related natural science field to qualify for this Life Sciences Job.
- Essential Knowledge & Experience:
- Proven professional experience working within a strict GMP-regulated pharmaceutical or commercial biotechnology manufacturing environment.
- Deep, practical knowledge of pharmaceutical microbiology assays, cleanroom classification standards, QC data documentation, and general corporate quality systems.
- Exceptional attention to detail, strong numerical reasoning traits, and an uncompromising approach to checking regulatory records.
- Excellent interpersonal and communication skills to collaborate smoothly with cross-functional manufacturing, laboratory, and supply chain teams.
- Absolute professional fluency in English (both written and verbal) is mandatory to author official corporate reports and liaise during international audits.
- Preferred Technical Assets:
- Prior hands-on familiarity or software configuration experience with specialized quality networks such as Veeva, MODA, LIMS, or equivalent electronic batch record systems is a highly distinct advantage.
In short, the QA Specialist position at Alvotech is a definitive route to transitioning your microbiology background or laboratory testing knowledge into a high-visibility global quality management asset. Securing an appointment here allows you to move past repetitive bench testing loops and take direct operational charge of the batch approvals, EM data summary reviews, and Veeva SOP networks that launch next-generation biosimilars onto global markets. If you reside in or can relocate to Reykjavik, meet the baseline science requirements, and possess an compromise-free commitment to tracking document accuracy, apply via the online portal before the July 20, 2026 deadline to secure this premier selection in a Quality Assurance Job, launch an exceptional Alvotech career, and lock in this outstanding Life Sciences Job.
