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Advanced QA Professional

3 months ago

Herlev, Denmark Nordic Bioscience AS Full time

Are you looking for a chance to use your solid QA experience in a dynamic and growing company? Do you want a unique position with broad responsibilities and high impact in a highly professional environment? And are you passionate about quality assurance, possess a keen eye for detail, and thrive in a collaborative environment? Then please read on.

Diverse QA role - Driving Quality Through Collaboration
You will join a small QA team of highly engaged QA professionals and report to the QA Manager. The responsibilities are diverse and include:

Bring expert support to the QA team and cross-functional project groups about industry standards and regulations (such as GMP, GCP, GCLP, CAP, CLIA, ISO9001, ISO13485, ISO15189, FDA 21 CFR part 11 etc.) As Nordic Bioscience expands, we are attracting increased attention from our clients. In close collaboration with your QA manager and colleagues, you will rotate through various roles during inspections from clients and authorities, including QA subject matter expert and audit host. Lead investigations into quality-related issues, perform root cause analysis, and implement corrective and preventive actions. Identify opportunities for process improvement, e.g. through internal audits, and overall enhancement of quality assurance practices with a focus on simplicity in all processes.

Experience and Drive
We seek a driven colleague passionate about continuous improvement of quality processes through close collaboration with stakeholders from other departments. You possess a deep understanding of GxP and industry standards, with a strong desire to advance and become a leading QA specialist.

Furthermore, we are looking for a candidate who: 

Has experience from QA roles within the pharmaceutical or biotech industry. Has a strong understanding of quality management systems and regulatory requirements, and expresses ideas and knowledge effectively. Enjoys being in the front and has flair for performing under high-pressure – e.g. in an audit situation where auditors challenge our processes. Expresses yourself clearly and precisely in English for both internal and external communication. Thrives in a dynamic environment and is adaptable to changing tasks and project teams. Has an innovative and solution-oriented mindset with the ability to think above and beyond own area to accommodate processes throughout the company during enhancement of quality.  

Working at Nordic Bioscience
Nordic Bioscience is a research-driven company specializing in the development of biomarkers for diagnostics and prognosis of various chronic diseases. Our laboratory, located in Herlev, conducts analyses of clinical samples for external partners, including CROs and Pharma/Biotech companies. 

Step into our CAP-accredited laboratory, committed to upholding the highest standards of quality. We specialize in delivering top-notch data crucial for decision-making in clinical trials throughout drug development. Your role in the daily operations of our company will be instrumental in maintaining our commitment to excellence and dedication to our clients.

Contact
We are actively scheduling interviews, so submit your application as soon as possible, and no later than 13 September 2024. If you have any questions about the position, feel free to reach out to QA Manager, Kirstine Lavrsen, at kla@nordicbio.com.