Lab Quality Manager (GA)-7126141013
Description
Ethicon USA, a member of the Johnson & Johnson Family of Companies is currently recruiting for a Lab Quality Manager to be based in Cornelia, GA. The position will require frequent visits to the Athens, GA facility and up to 10% domestic travel.
The Global Surgery Group is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Energy, Ethicon Biosurgery, Acclarent, Biosense Webster, Cordis, Mentor and Sterilmed. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Lab Quality Manager will report directly to the Site Quality Leader with a dotted line into the MD&D Regional Laboratory Leader and will support manufacturing and timely delivery of product to customers. The Manager position is responsible for the scientific leadership and management of the quality laboratory. The Lab Manager will oversee the Laboratory Out of Specification (OOS) and Out of Trend (OOT) test results investigations and ensure thorough root cause analysis and documentation. This position will serve as the technical expert and assist laboratory staff with troubleshooting as well as working actively with Managers and Supervisors for all disciplines in resolving corrective actions and timely completion of reports. The Lab Manager position will actively participate in process improvements and will assist with the development of laboratory procedures in accordance with current testing guidelines and current GMPs.
Major responsibilities will include:
Management and Leadership in a complex laboratory environment. Managing laboratory resources to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers. Ensuring all laboratory activities are conducted in accordance with government regulations, safety requirements, Enterprise, Sector and Company policies. Ensuring the appropriate oversight and guidance for laboratory 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 laboratory personnel have the required education and training to perform assigned job responsibilities. Ensuring all relevant core competency training modules are deployed to the laboratory personnel and that all laboratory procedures are aligned with the MD&D and Enterprise Laboratory Standards.
Ensuring that 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 Instrument Lifecycle and Laboratory Software Lifecycle systems. Oversight of all Laboratory Quality Systems including Laboratory Change Management activities. Review and approve Quality Records (e.g. non-conformances, CAPA) related to laboratory events. Provide audit support (front room, back room and SME). Reviewing and approving technical protocols and reports to support validation/verification and qualification 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.
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. 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. Assessing new technology and laboratory automation in collaboration with Regional Laboratory Leaders to increase laboratory efficiency, reduce testing time, reduce data variability, minimize chemical consumption and reduce waste. 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. Establishing and maintaining an annual operational budget. Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices. Serving as a departmental representative, as needed.
Qualifications
A minimum of a Bachelor’s Degree in Chemistry is required. A Master of Science or PhD is preferred. A minimum of 7 years laboratory experience in a GMP Laboratory environment is required. Pharmaceutical experience is required; experience with combination products is preferred. Experience with the following lab instruments is required: Lab Instruments: HPLC, UPLC, GC, UV-vis, FTIR, AA, ICP, XRF, Instron, and wet chemical techniques (Karl Fischer, titrations, etc).
Ability to develop strategies that deliver successful results to the business is required. Ability to interact with key internal and external stakeholders is required. Prior experience in a supervisory or people management capacity is required. Green Belt or Black Belt Certification is preferred.
Ability to define problems, collect data, establish facts and draw valid conclusions is required. Good interpersonal, organizational and communication skills are required. Ability to perform in a leadership role and to effectively manage people is required.
The position will be based in Cornelia, GA. It will require frequent visits to the Athens, GA facility and up to 10% domestic travel.
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Primary Location:North America-United States-Georgia-Cornelia
Organization: Ethicon Inc. (6045)
Job Function: Quality Assurance
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