Quality Lab Scientist Microbiology

仕事内容

The Quality Lab Scientist is responsible for executing and supporting the implementation of business improvement initiatives for Quality Operations Laboratories. He or she contributes to ensure compliance to JNJ and international Standards applicable to area of responsibility and drives forward the state of the art direction and best practices.

Duties & responsibilities

Under And In Accordance With All Applicable Federal, State And Local Laws/regulations And Corporate Johnson & Johnson, Procedures And Guidelines, This Position

• 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
• If Applicable responsibility for microbiological test methods and execution
• 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.
• Perform in and support Change Management Processes
• Assist the Quality Lab Scientist 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
• Analyze analytical (if applicable microbiological) data for significant quality trends and report conclusions for e.g. risk based decisions or improvement processes
• Presentation of data at DRB and Management Review
• Develop expert level of knowledge for LIMS and use it for implementation or establishment of compliance or business/process improvement
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
  
  

Experience and education

• University/ Bachelor’s Degree or Equivalent in a Life Science or Engineering
• Analytical and methodical problem solving
• Knowledge of regulatory requirements (MPG, MDD, 21CFR820, ISO 13485)
• Experience in GxP regulated industry
• Advanced computer skills and use of software applications
  
  

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.

• 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 is preferred.

• Independent working habit
• Good change Management experience
• Good communication skills and team experience