Quality Control Specialist II (m/f/d)

#LI-HybridLocation: Kundl, AustriaThis role is based in Kundl, Austria. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. We are looking for a highly skilled and motivated QC Specialist to join our Quality Control team. In this role, you will play a key part in ensuring reliable analytical results, maintaining GMP compliance, supporting laboratory investigations, qualifying analytical equipment, and reviewing analytical data. You will collaborate across functions and contribute to continuous improvement, inspection readiness, and the successful delivery of customer and quality projects.

We offer Two-year fixed-term contract with the possibility of extension.Major accountabilities:Lead and support investigations related to OOS, OOE, OOT, deviations, CAPAs, and action management, ensuring timely and compliant resolution.Review, approve, and ensure the integrity of analytical data, including IPC, release, and stability testing, in compliance with cGxP and data integrity requirements.Prepare and evaluate stability plans, protocols, trend analyses, comparative reports, and supplier qualification studies.Perform qualification and maintenance activities for analytical laboratory equipment and support analytical method validation.Update and maintain analytical methods, SOPs, aliquotation plans, and other GMP-relevant documentation.Monitor and evaluate KPIs and KQIs, including analytical lead times, error rates, stability trends, and compliance performance.Act as a subject matter expert during customer audits, health authority inspections, walkthroughs, and compliance reviews.Support digital quality control implementation and continuous improvement initiatives involving systems such as GLIMS, eLN, Empower, and related laboratory tools.Obligatory Requirements:University degree in biology, chemistry, pharmacy, or a related scientific field, or equivalent experience in a pharmaceutical or manufacturing analytical laboratory.Several years of experience in a GMP-regulated Quality Control environment, preferably within the pharmaceutical industry.Strong knowledge of cGxP, data integrity, TQM principles, QC testing, sampling, and laboratory excellence standards.Hands-on experience with analytical laboratory equipment, qualification activities, stability studies, and analytical documentation review.Strong analytical mindset with sound risk management, quality decision-making, and problem-solving skills.Ability to collaborate effectively across functions, manage priorities, provide feedback, and contribute to continuous improvement.Good knowledge of laboratory IT systems and applications, with awareness of information management and data security requirements.Proficiency in English and German, both written and spoken.Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave. Expected Annual Base Salary Range for role: Austria: EUR 59,782 – 95,800 The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.  In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.  Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf  Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.  Commitment to Diversity and Inclusion / EEO paragraph: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards