Description
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.
Key Responsibilities:
- 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
Qualifications
Qualifications
Education:
- University/ Bachelor's Degree or Equivalent in a Life Science or Engineering
- Advanced computer skills and use of software applications
Experience and Skills:
Required:
- German, fluent, native language preferred. English, fluent
- Demonstrated project management abilities
- Proficient in Microsoft Office —Word, Excel, and PowerPoint
- A thorough understanding of GMP (Good Manufacturing Practices)/ISO (International
Organization for Standardization) regulations
- Accurate and independent working methodology
- Analytical and methodical problem solving
- Good communication skills and team experience
- Experience in microbiology, GMP related topics, clean room qualifications, internal/external audits
- Experience in the execution, maintenance, and development of the environmental monitoring program
Preferred:
- Knowledge of regulatory requirements (MPG, MDD, 21CFR820, ISO 13485)
- Knowledge of room qualifications and method/device validation
- 3-5 years work experience in GxP regulated industry
- 2-3 years work experience in microbiological environment
- Experience in change management processes
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.