QA Specialist Serialization And Automation

Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson. The role is QA Specialist Serialization And Automation, located in Beerse, Belgium (must live close to a J&J Manufacturing site, such as Beerse or Geel in Belgium, Leiden in the Netherlands, Schaffhausen in Switzerland, Latina in Italy, or Cork in Ireland).

The contract runs for 1 year, with 32 to 40 hours per week (hybrid). The QA Specialist will act as the global Quality Representative on two critical cross-functional programs: upgrading existing serialization systems and implementing a new Manufacturing Digital Connect layer. Responsibilities include serving as the Global Quality SME on these program teams, leading development of one consolidated Global Serialization SOP suite, translating regulatory requirements into site-level quality requirements, leading training and competency activities, and understanding the quality impact of the new Manufacturing Digital Connect integration layer.

To succeed, you should have a strong background in Quality within pharmaceutical/biotech manufacturing, specifically focusing on serialization, track-and-trace, and global GxP SOP authoring. Requirements include medior to senior level experience in Quality or Serialization within pharmaceutical/biotech manufacturing; demonstrable experience with serialization and/or track-and-trace projects at a global scale; hands-on experience writing and implementing global GxP SOPs; practical familiarity with the EU Falsified Medicines Directive (EMVS/EMVO model), US DSCSA operational requirements, or China NMPA traceability expectations; strong SOP authoring, change control and risk assessment skills; technical understanding of serialization; Bachelor's degree in Pharmacy, Life Sciences, Engineering or comparable; technical understanding of manufacturing automation and Data Integrity; excellent stakeholder management and influencing skills; advanced degree preferred.

This role offers a very competitive hourly rate.