Johnson & Johnson Careers
Requisition ID: 1805699913W
The department Quality Assurance sees to that quality systems are applied as per GMP standards within Janssen Biologics and is responsible for handling non-conformances, bulk (PFB / FB) and intermediate (DPC / CSS) release and change control. The QA department plays an important role in providing advice on quality topics to all departments, which are part of the supply chain. To fill in the opening due to a leaving colleague, we are looking for an enthusiastic and driven new colleague who can take up this challenging role as QA Associate. If you would like to know the company better, then this a great opportunity!
- In case of non-conformances, you assess/review the outcome of the initial investigation and the proposed corrections. Furthermore you assess and oversee the quality of its related documentation.
- You are part of the investigation teams and monitor the quality of the Root Cause investigations. You assess potential consequences of non-conformances on the quality of our products.
- You review and sign of investigation related reports. Moreover you are responsible for the closure of the Quality Investigations and CPA records in Trackwise.
- You participate in (Global) escalations of issues, which have (potential) impact on the delivery of products to our patients.
- You participate in risk assessments as applicable.
- You are actively involved in initiatives that lead to higher quality and compliance awareness for the people on the shopfloor (Operations, One Lab, etc). You align and agree on improvement actions with the departmental subject matter expert and you follow up on the agreed solutions.
- Outside office hours you act as QA representative on a roulation basis with other colleagues and you can be reached by the pager or business mobile phone (24/7).
- You approve change notices (procedures) in name of QA and handle change controls in relation to CPA actions.
- You participate in NPI (New Product Introduction), quality and capacity projects.
Academic and HBO (higher education) in biochemistry, biology or a pharmaceutical degree, and depending on education, 5 to 7 years relevant working experience in a GMP environment.
- You can make well motivated decisions on your own.
- You have a great sense for quality and excellent analytical abilities.
- Experience in data analytics, vaccines and New product introduction is a pre.
- You have an excellent proficiency in English both in word and in writing.
- You have strong oral and written communication skills
- Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
Janssen Biologics (7266)