Microbiology Laboratory Team Leader

Job description

Ethicon Endo-Surgery, Inc. is currently recruiting for a Microbiology Laboratory Team Leader, which will be located in Albuquerque, New Mexico. The position will require 10% or less travel.

Ethicon Endo-Surgery, Inc. was created 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Microbiology Laboratory Team Leader will be responsible for:
• Carrying out the plant's Sterilization Dose Audit and Environmental Monitoring/Testing programs.
• Activities that apply to microbiological principles and procedures in the evaluation of processing and sterilization development projects.
• Reporting directly to the Area Manager or Supervisor and will support manufacturing and timely delivery of product to customers.
• Providing oversight to a small team in laboratory, which may be a second shift, or involved in a special project.
• The Team Leader will assign and direct that team to ensure that product testing is completed in a timely and compliant manner and is responsible for working with staff to troubleshoot instrument issues, investigate nonconforming data as well as review and issue Certificates of Analysis or Conformance as required.
• The Team Leader could be performing release testing and being involved as a technical leader approximately 20-40% of the time.
• Know and follow relevant policies, standards and procedures and ensure that direct reports know and follow policies, standards and procedures related to work activities performed in area of responsibility.
• Train lab personnel on microbial methods and techniques.
• Learn and introduce new laboratory technologies / techniques.
• Perform product testing involving more advanced training.
• Support product release and special project activities such as instrument qualifications and calibrations, method validation and transfer activities, laboratory investigations and troubleshooting activities.
• Execute the facility surface sampling program, including organism morphology. Review and compile the surface sampling data.
• Performing product testing and involved in activities leading to product disposition.
• Managing laboratory preparation/testing of samples from in process materials and finished product in support of the manufacturing schedule and to ensure timely delivery of product to customers.
• Develop, write, update and review test methods, SOPs, protocols, completion reports and specifications as required.
• Serving as Subject Matter Expert for testing methodology using knowledge of scientific techniques to independently troubleshoot product quality issues of a complex nature with a sense of urgency.
• Ensuring that all laboratory instruments and systems and software are maintained in accordance with procedures and standards.
• Ensuring that all laboratory activities are conducted in accordance with government regulations and safety requirements as well as all Enterprise, Sector and Company policies.
• Reviewing and approving quality records (e.g. non-conformance, CAPA as applicable) related to laboratory events.
• Drive investigation of non-conforming laboratory test results as well as reviewing and approving laboratory OOS and OOT events including related quality records and investigation reports. This will include ensuring that the reports are consistent, complete and in alignment with applicable standards and procedures including appropriate content and references.
• Escalating quality issues to management
• Monitor laboratory quality data and metrics on a regular basis to ensure that appropriate investigation, corrective action, and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists. This includes taking appropriate action to drive timely resolution of laboratory nonconformances and CAPA to meet applicable goals.
• If using a contract laboratory, monitoring data from the contract laboratory including non-conforming test results. Interfacing with contract laboratory during the laboratory investigation process.
• Ensure that associates have appropriate resources and support to execute testing in accordance with procedures, standards and regulations as well as ensuring that all relevant core competency training modules are completed by the laboratory personnel.
• Responsible for establishing and improving Quality Assurance practices and procedures associated with the Controlled Manufacturing Environments for Energy and Endo Mech Franchise Products.
• Maintaining up to date knowledge of the company's products and manufacturing processes related to relevant laboratory testing.
• When requested, providing audit support (front room, back room and SME).
• Maintain adherence to position training curriculum.
• Assure that team also adheres to position training curriculum.

Desired profile

• A minimum of a Bachelor's degree in Microbiology, Chemical Engineering or related Life Science is required. MS is preferred.
• A minimum of three years of experience in a GMP laboratory is required. Microbiological laboratory environment experience is preferred.
• A minimum of three years' experience in the quality area in the healthcare industry is preferred.
• Process Excellence Certification is preferred (Green / Black Belt).
• ASQ Certification is preferred.
• Previous experience in a leadership role and the ability to effectively manage people are required.
• Excellent interpersonal, organizational and oral and written communication skills are required.
• Skills in use of PC based systems including, but not limited to: word processing, inventory management, quality system, and nonconforming product systems and data base management are preferred.
• Skills of laboratory software / systems (IE: LIMS) is preferred.