Sr QA Associate
Sr. QA ASSOCIATE Location: Leiden, Netherlands Contract: Full Time/Contract
We are looking for an enthusiastic and motivated colleague who will help us to strengthen our QA team of Janssen Biologics, somebody who would like to contribute to a high quality organization of the site and J&J.
The Sr. QA associate will be the linking pin in the investigations into quality issues and with that responsible for the improvement of the overall quality status of the commercial products production. You will work in close collaboration with other departments (Operations, Warehouse, One Lab, MAM and Technical Operations).
The activities are very dynamic and varied. The candidate likes challenges, doesn’t avoid problems and enjoys working is various teams.
About the Company: 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 in Leiden is currently manufacturing COVID 19 vaccine (Drug Substance) vaccine. Janssen Biologics is part of the Johnson & Johnson family of companies. 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 a meaningful role in providing advice on quality topics to all departments of the supply chain.
To fill in this phenomenal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role as Sr. QA Associate. The responsibilities & the impact YOU will have:
- Be the the lead contact for departments we work with
- Quality Owner for commercial products
- Ensure that in a timely manner a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations. Lead all aspects of site investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
- Raise serious quality, compliance and /or GMP incidents to Site or Global Management.
- Setup and coordinate Site and Global critical issue meetings.
- Act as quality specialist and participates in the preparations for and during inspections (FDA, EMA etc.) to accomplish a successful audit.
- Perform level assessment, review and approval of (deviation related) change controls.
- Partner with site colleagues to ensure all site changes and projects are conducted in a compliance to cGMP and company quality requirements.
- Act as a QA-representative during non-office hours and is therefore reachable through telephone. The QA-Associate will only return on site in case of serious quality incidents for which an immediate on-site assessment is required.
- Assess, review and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g. but not limited to stability, validation, analytical technical transfer
- Act as member in Quality Risk Management and /or root cause investigation sessions.
- On a rotation basis is available 24/7 as QA representative for Quality issues
Minimum education required for the position:
We would love to hear from YOU, if you have the following essential requirements
- Msc in science related subject and/or business-related area with 6years of experience.
- familiarity with PE. LEAN tools concepts and methodologies.
This is what awaits YOU at J&J: This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether you’re one of the ~1000 people who work here, or you’re considering joining the team, we offer:
- Flexible working hours
- Your change to be part of a global market leader.
- A dynamic and inspiring working environment.
- Opportunities to work on exciting projects and assignments