Quality Systems and Training Specialist

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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

Job Description:

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.

Quality Systems Responsibilities

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.

Training System Responsibilities

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. Conduct periodic training-system reviews and spot audits to verify compliance and identify opportunities for improvement.

21. Assist with controlled-document distribution and documentation compliance for operational areas.

22. Conduct or support investigations of nonconformances associated with the training system or potential human-error factors.

23. Deliver orientation, induction, quality-system, and required site training to new employees.

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