Yacht Life Sciences has a vacancy for a Release & Stability Coordinator - Quality Control (QC) to work at Janssen Biologics in Leiden

We're looking for an enthusiastic coordinator to join the Quality Control (QC) team. In this team the employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

• Fully owns end-to-end product testing process within Leiden QC independently
• Coordinates the release of raw materials drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines.? 
• Coordinates the stability testing of JSC large molecule products according to local procedures and agreed timelines.?  
• Is a technical leader on biologics and/or vaccines release and stability testing processes and has a leading role during the GMP inspections. 
• Participates in meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience. 
• Responsible to coordinate all data requests?provided by various stakeholders (e.g. RA. Health Authority, DPDS)?and has the?accountability?to plan, organize, prioritize and?execute?the data Requests based on the stakeholder requests. 
• Responsible for reviewing the CPV plans and matrixes and update the QC release trend limits accordingly.
• Provide input for the YBPR and APR requests.
• Leads and drives continuous improvement projects. 
• Influences, develops and executes strategy for expertise area.
• Trains and mentors colleagues in expertise area.
• Proactively shares knowledge with team and other sites and functions to drive improvement and alignment.
• Adhere to compliance best practices, EHSS regulations and lean principles. 
• Perform other work-related activities assigned by supervisor. 
• Maintain compliance with all company policies and procedures.