Yacht Life Sciences has a vacancy for a Quality Assurance (QA) Associate to work for Janssen Biologics in Leiden and take part in their COVID-19 vaccine project.
For the QA New Product Development (NPD) & Launch department, we are currently looking for a QA Associate, with strong knowledge of both cGMP guidelines and Quality Management systems. As an enthusiastic QA Associate NPD & Launch with a strong sense of urgency and a passionate commitment to getting things done, you will contribute to the Quality support for all New Products quality related topics within the Leiden manufacturing site (i.e. development departments, production facilities and quality control labs).
You will provide independent reviews and ensure that a clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. The QA Associate works in close collaboration with other departments (Operations, One Lab, Engineering, Vaccines Launch Facility and Development Departments). In this position you report to Sr Manager QA NPD & Launch and will work together with QA officers and QA Associates.
Day to Day Responsibilities:
- Participate as Core Team Member in New Product Introduction projects
- Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations
- Provide Quality support for the development of appropriate Corrective and Preventative actions
- Support (Global) escalation of issues, which have potential impact on the delivery of products to our patients
- Participate in risk assessments to ensure compliance or quality is not jeopardized
- Act as trainer for the use of Quality processes
- Is involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing areas and the laboratory
- Provide review and approval of document changes and change controls
- Lead or act as member for local or global capacity/quality projects
- Optimize current and identify new ways of process and quality monitoring
- On a rotation basis is available 24/7 as QA representative for Quality issues
- Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
- Proven knowledge of the biotechnological/pharmaceutical industry and 5 years working experience in a GMP regulated environment (manufacturing, QA and/or QC)
- Knowledge and Experience in vaccines is a pre
- Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
- Working knowledge with Trackwise, SAP systems
- Experience in data analytics and data visualization
- Proficiency in Lean or Six Sigma
- You have an excellent proficiency in English both in word and in writing
- Ability to drive collaboration in a fast-paced environment
- Excellent analytical abilities, eye for details
- Empowered professional who can make well motivated pragmatic decisions on their own
We offer 3 challenging positions which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is possible). This position is open for freelancers/ ZZP as well.
We will offer a competitive benefits package in line with the seniority of the position (salary between 4500 and 5500 euro gross per 4 week period). You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics is part of the Johnson & Johnson family of companies.
At Quality Assurance, they take a stand to consistently ensure the delivery of safe, cost effective and high-quality products for the patients in need. The QA department has a commercial and an NPD (New Product Development) & Launch branch. This position will be placed within the NPD & Launch group. QA NPD & Launch provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation and batch disposition) for their new biological products and vaccines. These products will be used in Clinical Studies to prove their safety and efficacy prior to their commercialization. This is a quick evolving and dynamic environment.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.