Microbiology Team Leader

Description:

Omrix Biosurgery Israel is looking for a Microbiology Lab Team Leader.

These are the General responsibilities of the role:

• Reports directly to the QC Senior Manager
• Responsible for providing support to the Quality Control (QC) Analytical laboratory. Reviews analytical documentation and ensures compliance in all aspects of the laboratory function.
• Manages the QC laboratory workflow. Supports production by performing material/product testing, writes/modifies production documentation, determines priority for analysts. Develops, maintains, modifies and implements quality levels and sampling plans for incoming, in process and final inspections to ensure conformance. Writes and reviews material compliance for final product release. Oversees laboratory investigations and provides technical assistance to all team members. Recognizes and troubleshoots malfunctioning instruments and suggests likely causes. Investigates specifications and suggests possible causes and investigation strategies. Interacts with team to review and obtain sample data for trending purposes and for future acting on common issues. Works closely with development group for the validation and transfer of methods to the laboratory. Tracks and trends laboratory deviation and investigation as required and prepares report for management review. Demonstrates innovative/creative approach in solving technical problems and troubleshooting with little or no assistance from management or other scientific personnel while maintaining a high level of safety compliance. Suggests continuous improvements for laboratory operations and efficiency. Implements ideas when warranted.
  
  

• Management and Leadership in a laboratory environment for Microbiological Laboratories.
• Communicates department objectives and metrics.
• Managing Microbiology laboratory to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers.
• Ensuring all Microbiological laboratory activities are conducted in accordance with government regulations, safety requirements, Enterprise, Sector and Company policies.
• Ensuring the appropriate oversight and guidance for microbiology laboratories investigations including reviewing investigations to ensure that reports are consistent, complete and in alignment with applicable standards and procedures with appropriate content and references.
• Ensuring cGMP compliance in all aspects of the laboratory functions.
• Ensuring that all microbiology laboratory personnel have the required education and training to perform assigned job responsibilities.
• Ensuring that microbiological laboratory equipment and systems are maintained in accordance with procedures and standards.
• Ensuring that validated/verified test methods and qualified and calibrated instruments are used for quality testing activities.
• Oversight of Laboratory Instrument Lifecycle and Laboratory Software Lifecycle systems.
• Oversight of all Laboratory Quality Systems including Micro Laboratory Change Management activities.
• Oversight of Quality Agreements with Contract Laboratories to ensure excellent and appropriate communication between laboratories. Additionally, working with procurement to develop business agreements with Contract Laboratories.
• Reviewing and approving technical protocols and reports to support validation/verification and qualification activities.
• Monitoring laboratory metric trends on a regular basis and ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists.
• Providing audit support (front room, back room and SME) in microbiological field.
• Leading/sponsoring the implementation of improvement initiatives to address recurring laboratory issues.
• Monitoring the progress and process for troubleshooting and investigation studies for laboratory issues to ensure appropriate and consistent use of investigative tools and problem-solving techniques.
• Reviewing and approving Quality Records (e.g. non-conformances, CAPA) related to laboratory events.
• Maintaining up to date knowledge of the company’s products and manufacturing processes as wells as industry and regulatory trends related to relevant laboratory testing.
• Communicating and elevating critical business-related issues as well as opportunities to senior management.
• Planning, promoting and organizing required training activities related to different laboratory testing areas.
• Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices.
• Serving as the Departmental representative as needed.
• Performing other related duties as assigned by management.
• Auditor of second signature verification and ensuring GDP of test method verification.
  
  

• University/bachelor's degree or Equivalent (B. science is preferred)
• Experience as a Lab Lead - a must
• 4 years Experience in GMP Micro Laboratory - a must
• High level of both English and Hebrew - a must