Ethicon Endo Surgery Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Microbiology Lab Technician to be located in Albuquerque, New Mexico.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
Works under the direction of the Quality Assurance Organization and is responsible for providing support to the Microbiology Lab QA Team and the Sterilization Quarterly Audit Program to achieve quality, efficiency, and cost targets, while ensuring compliance to all applicable standards.
• Provide support and execution for Sample Item Portions (SIP s) preparation, testing, documentation, reporting, and conclusions.
• Provide support and execution for the Environmental Monitoring Program (EM) for the Albuquerque Facility.
• Provide support of activities and serve as a resource for quality issues and initiatives.
• Coordinate with Manufacturing Operations to schedule and retrieve audit product samples in a timely manner.
• Perform physical manipulation of products into SIPs under aseptic conditions.
• Aseptically package and ship SIPs to testing laboratories.
• Maintain Laboratory equipment and supplies for SIPs and EM.
• Maintain accurate records verifying that required samples have been collected, processed and dispersed to appropriate testing laboratories.
• Review the incoming data for completeness and adherence to specifications.
• Maintain communication links between different testing laboratories to ensure timely testing and accuracy of samples.
• Create and Maintain laboratory procedures and governing documents.
• Assist QA team with audits to assess compliance to GMP, ISO, and EES standards.
• Support QA Team on a daily basis for SIPs and EM.
• Coordinate and execute the EM Program, which includes but not limited to particulate, viable air and surface testing.
• Compile and review EM testing results.
• Coordinates discussions with Quality, Engineering, Operating Companies, Regional Lab Managers and other business partners to ensure department objectives are met.
• Writes and executes protocols as necessary.
• Performs complex tests and data analyses to recommend disposition of material.
• Provide support as needed to manufacturing operations to determine the root cause of EM and/or SIPs failures.
• Provide support to QA Team in continuous improvement activities as they relate to the education of product inquiries or other COGS initiatives
• Maintain knowledge of all procedures, change to specifications (Process, Training Manuals,
• Material Specifications, etc.), and regulations related to their area of responsibility.
• Maintain process knowledge for the assigned area of responsibility.
• Works with QA Team on document and process improvements, including but not limited to data collection, ECNs, and additional training as required.
• Provide materials/communication or service to customers in a timely manner.
• Recommends and implements revisions, corrections, and changes to test equipment, procedures, and methods.
• Provide support and initiative to the QA organization through continuous improvement projects.
• Provide necessary feedback to customers.
• Coordinates discussions, written reports, and oral presentations with business partners regarding quality issues, projects, and activities as required.
• Exercise initiative and ingenuity to deal with varying circumstances and changing conditions, referring unusual situations to QA Team.
• Provide support with project completion and project enhancements.
• Provide coverage and coordination for absences as required.
• Provide leadership to team as appropriate.
• Work cooperatively toward effective outcomes.
• Work to resolve differences in a collaborative effort.
• Follow all company safety policies and other safety precautions within the work area.
• Promote safety to all associates that enter the work area.
• Attend required safety training
• Participate in implementation of the EMS management system including continual improvement, pollution prevention, objectives and targets, and regulatory compliance.
• Implement and follow all applicable EMS procedures.
• Adhere to the site’s EHS Code of Conduct.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned.
• Maintain adherence to position training curriculum, including J&J Microbiology Training Modules.
• Training Plan Requirements as identified in Corporate Training Procedure, CP0128.
• Applicable training plan for the area of support.
• High school diploma or equivalent required.
• Associates Degree, trade school, or some college preferred.
• Minimum one year experience with manufacturing operations, preferably in the medical device industry.
• Quality systems experience is preferred.
• General knowledge of medical devices preferred.
• Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.
• General knowledge of Microbiology terminology preferred.
• Knowledge of Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook is required.
• Requires long periods of walking, standing, bending, stooping and reaching.
• May require lifting of boxes or material not to exceed 50 lbs.
• May require use of a pallet jack.
• Must maintain vision certification through the visual acuity testing/process.
• Hours are generally 1st shift Monday-Friday, but requires flexibility to include some nights, weekends and holidays for special projects and emergency.
United States-New Mexico-AlbuquerqueOrganization
Ethicon Endo Surgery Inc (6041)Job Function