Ethicon USA, a member of the Johnson & Johnson Family of Companies is currently recruiting for a Laboratory Manager, Quality Assurance 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.
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 of the laboratory in a complex manufacturing 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 all applicable government quality regulations, safety requirements, and J&J 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 that all laboratory personnel are appropriately trained and records maintained.
• Ensuring that laboratory equipment and systems are maintained in accordance with procedures and standards.
• Oversight of Instrument Lifecycle, Laboratory Software Lifecycle systems, Laboratory Quality Systems including Laboratory Change Management activities.
• Review and approve Quality Records (e.g. non-conformances, CAPA) related to laboratory events.
• Provide support to internal and external audits. Reviewing and approving technical protocols and reports to support validation/verification and qualification activities.
• Oversight of interactions with Contract Laboratories to ensure effective communication and project management. Additionally, working with internal business partners to develop Quality Agreements and work plans 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.
• Assessing new technology and laboratory automation in collaboration with colleagues throughout Johnson & Johnson 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 or related science (such as Materials Science or Pharma Science)
• A minimum of 7 years’ laboratory experience in a GMP Laboratory environment.
• Experience with the following lab instruments: Lab Instruments: HPLC, UPLC, GC, UV-vis, FTIR, AA, ICP, XRF, Instron, and wet chemical techniques (Karl Fischer, titrations, etc).
• The ability to develop strategies that deliver successful results to the business
• Ability to interact with key internal and external stakeholders
• Prior experience in a supervisory or people management capacity
• Ability to define problems, collect data, establish facts and draw valid conclusions
• Good interpersonal, organizational and communication skills
• Ability to perform in a leadership role and to effectively manage people
• A Master of Science or PhD in Chemistry or related science
• Experience with combination products and/or pharmaceuticals
• Green Belt or Black Belt Certification is preferred
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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J2W: LI NAPrimary Location
Ethicon Inc. (6045)Job Function