Quality Systems and Training Specialist

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:
Quality Job Sub Function:
Quality Systems Job Category:
Professional All Job Posting Locations:
Jacksonville, Florida, United States of America

Establishes, maintains, and supports quality assurance and employee training programs, procedures, systems, and controls. Ensures that quality-system performance, employee qualification, and training compliance are continually monitored and measured to support regulatory compliance and continuous improvement. Designs, develops, delivers, and evaluates technical, cGMP, quality-system, and employee-development training programs. Maintains accurate and current training records, administers the Learning Management System, supports employee certification, and provides management with quality and training compliance information.

Supports quality-system monitoring, data trending, procedure development, management review, audit readiness, product review and release activities, and site compliance with applicable company, safety, environmental, and regulatory requirements.

• 1. Monitor and track sources of quality detractors using applicable quality systems, records, databases, and performance metrics.
• 2. Ensure compliance with company policies, procedures, quality standards, and applicable safety and environmental requirements.
• 3. Support the development, review, revision, and implementation of standard operating procedures and other controlled quality-system documents.
• 4. Generate quality metrics, statistical summaries, and trend reports. Communicate significant trends to management and appropriate cross-functional teams.
• 5. Use quality tools, data, and system-generated reports to support continuous improvement of quality-system and process performance.
• 6. Provide support for product review and release activities, as applicable.
• 7. Support good manufacturing practice audits, regulatory inspection readiness, internal assessments, and other site-readiness activities.
• 8. Collect and consolidate quality-system inputs for management reviews, data review boards, and other quality governance forums.
• 9. Verify that quality-system elements are effectively deployed by conducting periodic checks, assessments, and compliance reviews.
• 10. Support quality-system applications and processes, including document management, change control, nonconformance, CAPA, audit, and metrics-reporting systems.

• 11. Design, develop, deliver, and evaluate technical, cGMP, quality-system, and operational training programs and materials for instructional effectiveness.
• 12. Collaborate with Engineering, Quality, Operations, and other functional areas to identify training needs and deliver programs supporting site operations.
• 13. Evaluate procedure and document changes to determine affected audiences, training requirements, and appropriate training methodologies.
• 14. Coordinate employee training activities and ensure that required training is completed and properly documented.
• 15. Support the qualification and certification of employees to perform assigned job responsibilities.
• 16. Maintain accurate employee training plans, curricula, qualification records, and certification information.
• 17. Administer and maintain the Learning Management System and associated training documentation in accordance with applicable procedures and record-retention requirements.
• 18. Ensure that training documentation is accurate, current, readily available, and maintained in accordance with established procedures and applicable requirements.
• 19. Provide supervisors and management with employee training, qualification, certification, and compliance status information.
• 20.…