Technical Specialist QC Microbiology
About the Company
Janssen Biologics in Leiden, the Netherlands, is a leading production site within Janssen and part of Johnson & Johnson Innovative Medicine. At the Leiden site commercial pharmaceutical products are being produced and new products are being developed and produced for clinical trials and early launch. At Janssen hardworking people are working together in a dynamic culture where innovation and a 'can do' state of mind are common good. We are proud of our Credo & diverse culture. The site is steadily growing and redefining to support our patients, while committing to the highest safety & sustainability standards!
The responsibilities & the impact YOU will have
The Technical Specialist/Scientist will actively handle medium and high quality and compliance issues at the lab independently or with help of the lab technicians. Will work to maintain cGMP compliance and LEAN status of the team. Act as Subject Matter Authority during cGMP inspections and is SPOC (Single Point Of Contact) for the lab during new product implementations, investigations, qualifications, etcetera.
Your key responsibilities:
- Responsible for deviation management, acting as lead investigator for non-conformances and coordinator of appropriate corrective/preventive actions.
- Creates, reviews and updates lab documentation and supporting documents for New Product Introductions.
- Provides technical support to the lab, input in services group and collaborates with local/global customers.
- Acts as a technical system owner for (analytical) equipment.
- Acting as Subject Matter Authority during audits and inspections.
- Leads and drives continuous improvement projects.
- Role model to safety, compliance, and reliability
- Responsible to communicate and interact effectively with team members; develop credibility and trusted mutually respected relationships with customers, supervisors, and team members.
