Quality Control Laboratory Leader

Company: Disability Solutions
Location: Irving
Posted on: February 8, 2025

Job Description:

Johnson & Johnson is seeking a Quality Control Laboratory Leader to be located at Irving, TX.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.The QC Laboratory Leader will provide leadership and advice for the Quality Control group with the ability to inspire and motivate others and act as a change agent to drive lab and sterilization assurance improvements and efficiencies. Responsible for managing and coordinating the activities of the Quality Control associates engaged in sorting, testing, and inspecting products and raw materials in order to ensure compliance with quality standards and production schedules. Supervises lab personnel and oversee lab personnel including development and leave. This position provides quality technical support for the sterilization related processes.Key responsibilities:

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• Oversees the development and implementation of processes, procedures, and response to audits and corrective actions.
• Ensures effective communication and training are deployed throughout the business related to Quality Control activities.
• Implement change management initiatives that provide an efficient, productive, compliance through data driven decision making, and flexible laboratory at the Irving Operations site.
• Directs shifts in priorities based on business demands and provide technical expertise for laboratory testing and sterility assurance.
• Write and oversee/conduct validation protocol and reports for test methods, equipment and lab software.
• Provide technical guidance for the execution for laboratory testing necessary to support product/process qualifications and research and development projects.
• Provide support for investigation into lab out of specification results and nonconformance records.
• Compile and analyze test information to determine the efficiency of process or equipment and to diagnose malfunctions.
• Support internal and external audit activities.
• This position may represent the laboratories in meetings to ensure effective communication of the production and/or project needs to the laboratory and may oversee laboratory personnel including development and leave.
• Coach, develop, and mentor team
• Help shape and deliver the lab strategy ensuring effective communication to team and wider audience where required
• Make appropriate decisions in conditions of complexity and ambiguity, understanding the big picture consequences of decisions
• Subject Matter Expert in lab operations
• Participate in third party inspections, representing laboratory operations and sterilization assurance.
• Partner with management to develop and implement meaningful trending of quality control performance.
• Leverage Process Excellence tools to effectively implement improvement or corrective actions.
• Responsible to mentor both technical and non-technical resources in investigation, troubleshooting, escalation, and resolution of product and process quality issues, LIRS, NCR and CAPA.
• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• 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
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed\r\r

Keywords: Disability Solutions, Irving , Quality Control Laboratory Leader, Healthcare , Irving, Texas