Commercial Quality Staff Engineer

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 Med Tech, 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.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Supply Chain Engineering

Job Sub Function: Quality Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Shepherdsville, Kentucky, United States of America, Somerset, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for Commercial Quality Staff Engineer to work onsite at Somerset, NJ and/or Shepherdsville, Kentucky.

The Commercial Quality Staff Engineer is responsible for the oversight and execution of Quality Management Systems and compliance at the U.S. Pharma Distribution Centers. The Quality Engineer provides leadership and support of investigations, validations, quality system improvements, and audit readiness for the Distribution Center. Also monitors and reports on all quality system categories to assess compliance to GxP, regulatory, and standards.

The Commercial Quality Staff Engineer serves as a single point of contact to the Commercial Quality Manager and Supply Chain partners on compliance related matters and is the liaison with multiple quality compliance organizations to drive timely resolution of quality and compliance related issues. Also, identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions.

The Quality Engineer implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.

• Promote culture of continuous quality improvement and provide visibility to quality system performance through accurate metrics and reports.
• Supports the U.S. Pharma Customer Support Services Team with quality and compliance related matters and Delivery Service Issues (DSIs).
• Support internal and external quality system audits.
• Supports process qualification activities by developing and/or approving validation documentation.
• Leads quality and compliance projects as needed.
• Participates in developing and presenting departmental materials for Management review.
• Assists project teams with identification of quality system requirements to ensure compliance.
• Leads and supports Master Data, i.e., sIDMa, activities for the Distribution Center and provide quality support for the U.S. Pharma Distribution Centers.
• Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner.
• Identifies opportunities to continuously improve quality, cost, and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives.
• Identifies business issues, communicates to management, prioritizes for action, and leads improvement, and opportunities and problem solutions in collaboration with other Supply Chain partners.
• Responsible for monitoring of material destruction authorization (MDA) process.
• Responsible for audit inspection readiness activities and assisting in Health Authority and Regulatory Inspections including, but not limited to, TSA, DEA, FDA, and VAWD.
• Responsible for partnering with TS (Technology Services) on warehouse management system changes and testing activities.
• Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
• Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems.
• Additionally, responsible for review and approval of records.
• Responsible for adherence to the Records Management and Retention processes.
• Responsible for adhering to the Training process.
• Responsible for supporting the Quality Agreement process.
• Responsible for supporting internal and external…