QA Laboratory Team Lead

Ethicon, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a QA Laboratory Team Lead located in Cornelia, GA or Athens, GA. Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com. JOB SUMMARY The Team Leader will report directly to the Laboratory Manager or Supervisor and will support manufacturing and timely delivery of product to customers. The Team Leader is responsible for providing oversight to a small team within the quality laboratory. The Team Leader will assign and direct that team to ensure that product testing is completed in a timely and compliant manner. The Team Leader 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. In addition, the Team Leader is responsible for performing release testing approximately 50% of the time. Approximately 50% of the time, the Team Leader will be involved as a technical leader. DUTIES & RESPONSIBILITIES Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: 1. Performing product testing and involved in activities leading to product disposition. 2. Managing and scheduling laboratory testing of raw materials, in process materials and finished product in support of the manufacturing schedule and to ensure timely delivery of product to customers. 3. When acting in an oversight role, ensuring that all laboratory test methods and procedures are executed in compliance with specifications and standards. Additionally, working in the development, writing, updating and review of test methods, SOPs, protocols, and specifications as required. 4. 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. 5. Ensuring that all laboratory instruments and systems and software are maintained in accordance with procedures and standards. 6. Ensuring that all laboratory activities are conducted in accordance with government regulations and safety requirements as well as all Enterprise, Sector and Company policies. 7. Reviewing and approving quality records (e.g. non-conformance, CAPA) related to laboratory events in his/her laboratory. 8. Within the specific team, driving the 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. 9. Escalating quality issues to management. 10. Working with the Supervisor to 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. 11. If team is using a contract laboratory, monitoring data from the contract laboratory including non-conforming test results. Interfacing with contract laboratory during the laboratory investigation process. 12. Assisting the Supervisor in the developing, training and coaching of lab associates within the team. This includes ensuring 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. 13. Maintaining up to date knowledge of the company’s products and manufacturing processes related to relevant laboratory testing. 14. When requested, providing audit support (front room, back room and SME). 15. Working with cross functional teams to successfully resolve audit findings, product non-conformances, customer complaints, to execute Corrective/Preventive Actions and/or to improve product design. 16. Assisting the Supervisor in the monitoring of departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices. 17. Ensuring the timely completion of document reviews and approvals for document changes within their area of responsibility 18. Participating in budget planning for the laboratory. 19. Responsible for communicating business related issues or opportunities to next management level 20. 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 21. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures 22. Performs other duties assigned as needed Major Responsibilities may include: 1. Performing product testing involving more advanced training 2. Working closely with the laboratory Supervisor in support of product release, and special project activities such as instrument qualifications and calibrations, method validation and transfer activities, and laboratory investigations and troubleshooting activities Qualifications • A Bachelor of Science Degree is required. A Master of Science or PhD is desired • Minimum of 6 years of experience in a GMP laboratory is required • Minimum of 2 years’ experience in a GMP laboratory with Master of Science Degree or PhD REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS. • Ability to perform in a leadership role and to effectively manage people • Good interpersonal, organizational and oral and written communication skills • Must be able to interact well with peers and colleagues • Self-motivated • This role may require up to 10% of domestic and international travel ADDITIONAL POSITION REQUIREMENTS • Work in team environment behaving in a CREDO based respectful manner. • Comply with all federally regulated programs. • Adhere to J&J environmental and safety policies and guidelines. • Comply with all job specific safety procedures and utilize PPE when necessary. • Comply with quality system requirements as defined within procedures and instructions. • Use test equipment or instrumentation where applicable. • Utilize applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, etc.) • Consistently meet required work performance targets (RE’s), if applicable • Support LEAN and Six Sigma Initiatives. • Support Maintenance Excellence (ME2) including 6S and Operator Asset Care. • Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation). • Perform other work-related duties as assigned by supervisor. • Consistently meet required Training due date targets. • Requires ability and flexibility for working hours which includes overtime and weekends as needed 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. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-Georgia-Cornelia-655 Ethicon Circle Other Locations North America-United States-Georgia-Athens Organization Ethicon Inc. (6045) Job Function Quality Requisition ID 2206065347W