Johnson & Johnson Medical Devices, a member of the Johnson & Johnson family of companies is recruiting for the office in Norderstedt, Germany a:
Quality Lab Scientist (m/f/d) (Temporary 2 years)
The Quality Lab Scientist is responsible for executing and supporting the implementation of business improvement initiatives for Quality Operations Laboratories. He or she defines opportunities, analyzes data with cross functional partners and implements improvements. He or she ensures compliance to JNJ and international Standards applicable to area of responsibility and drives forward the state of the art direction and best practices.
- Collaborate in Quality Operation Projects to plan, prepare, execute and/or support equipment qualification, test methods validation or computer system validation complying with local and global regulatory requirements as well as J&J standards
- Support Compliance Projects and implements actions which result from new standards, Non Conformances, Audits or CAPAs
- Support and initiate Quality Operation Projects including but not limited to: Cost Improvement, System Changes, LEAN, New Software Systems, etc.
- Develop expert level of knowledge for LIMS and use it for implementation or establishment of compliance or business/process improvement
- Perform in and support Change Management Processes
- Assist the Quality Lab Supervisor in establishing the QO Laboratories projects and initiatives
- Support the Quality Lab Scientist Supervisor and other Lab Supervisors in developing, coordinating and implementing projects for improvement of processes
- Implement and establish Data Integrity for the QO Laboratory Equipment complying with regulatory requirements as well as J&J standards
- Supports facility management and the operations department in clean room qualifications
- Responsible for microbiological test methods and execution
- Supports the Quality Lab Supervisor in maintenance of the environmental monitoring program (analysis of significant quality trends, report of conclusions for e.g. risk based decisions) and microbial release
- Assists the team in assessment of nonconformances, out of trend, out of spec events, develops solutions and supports product dispositions