QA Assistant In QA Commercial Support

QA Assistant At Ascendis Pharma

Do you want to combine your academic studies with real life experience in an international and growing pharmaceutical company and support the Quality Assurance processes? Then here is your chance to start your career as a QA Assistant at Ascendis Pharma.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients' lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

You will get the opportunity to work side-by-side with highly experienced QA Managers and become familiar with quality assurance processes and systems. Furthermore, you will be working closely with other QA Assistants in the team.

We are looking for a passionate student for our QA Commercial Support team. The main responsibilities include handling of batch documentation as well as support in the review of batch records. There will be possibilities to suggest, support or even independently drive improvements of our internal systems and processes.

Your key responsibilities:

• Secure retrieval and quality of batch documentation in relation to the QA processes
• Storage of batch documentation from our CMOs in Ascendis Pharma's internal document handling system
• Prepare disposition forms and support review of batch records from manufacturing of starting materials, intermediates, drug substance, drug product and finished goods
• Collect and analyze data about performance and quality KPIs
• Identify and drive improvements, internally and externally
• Other ad hoc, day-to-day tasks and support of needs in the team

The preferred candidate:

• Good interaction and collaboration competences
• Great communication skills in English
• High level of experience in using MS Office, especially Excel and Word, and also Outlook
• Keen to learn and develop professionally and personally in a pharmaceutical company environment
• Studying natural sciences, e.g., pharmacy, chemistry, biology, engineering (1 or 2 years into your studies)
• Ability to work 8-15 hours per week (flexibility offered by Ascendis Pharma during periods of study exams)
• Detail oriented, systematic, self-starter and learn at a quick pace

You are a highly motivated person who enjoys being challenged and working in collaborative and ambitious settings, where you can structure, follow up on and complete your tasks. You can work independently and with little supervision. You are conscientious about your assignments and responsibilities, and you are focused on finding solutions and on meeting deadlines.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.

For more details about the job or the company, please contact Christian Borch Hansen, Senior QA Manager in QA Commercial.