Ethicon, a member of Johnson & Johnson's Family of Companies is recruiting for a QA Laboratory Team Lead located at Cornelia, Georgia.
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 (http://www.ethicon.com/).
The Team Leader reports directly to the Laboratory Manager or Supervisor and will support 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 assign and advise the 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 the need arises.
- Performs product testing and involved in activities leading to product disposition.
- Lead and schedule the 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.
- As the Subject Matter Expert for testing methodology, troubleshoot the product quality issues of a sophisticated nature with a sense of urgency.
- Responsible to review laboratory instruments, systems and software to ensure are maintained in accordance with procedures and standards.
- Ensures all laboratory activities are conducted in accordance with government regulations and safety requirements as well as all Enterprise, Sector and Company policies.
- Drive 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.
- Collaborate on review the laboratory quality data and metrics on a regular basis to ensure that appropriate investigation, corrective action, and/or escalation is conducted as the need arises 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.
- Assist 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 complete testing in accordance with procedures, standards and regulations as well as ensuring that all relevant core proficiency training modules are completed by the laboratory personnel.
- Work with cross functional teams to successfully resolve audit findings, product non-conformances, customer complaints, to implement Corrective/Preventive Actions and/or to improve product design.
- Ensure the timely completion of document reviews and approvals for document changes within their area of responsibility
- A minimum of a Bachelor’s Degree Science is required. Degree in Chemistry is preferred.
- A minimum of 6 years of work experience in a GMP laboratory is required.
- Ability to perform in a leadership role and to effectively lead people are preferred.
- Good interpersonal, organizational and oral and written communication skills is preferred.
- Leadership skills are preferred.
- This position may require 10% domestic travel
- This position will be primarily located in Cornelia, GA but will also require onsite support in the Athens, GA facility.
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.
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