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 main focus will be lab related quality issues, but can vary over time.

The 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.

The activities are very dynamic and varied. The candidate likes challenges, doesn’t avoid problems and enjoys working is various teams.

To fill in this phenomenal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role as QA Associate. The responsibilities & the impact YOU will have:

• 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.