Quality Systems and Training Specialist

Quality Systems Responsibilities

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

Training System Responsibilities

• Design, develop, deliver, and evaluate technical, cGMP, quality-system, and operational training programs and materials for instructional effectiveness.
• Collaborate with Engineering, Quality, Operations, and other functional areas to identify training needs and deliver programs supporting site operations.
• Evaluate procedure and document changes to determine affected audiences, training requirements, and appropriate training methodologies.
• Coordinate employee training activities and ensure that required training is completed and properly documented.
• Support the qualification and certification of employees to perform assigned job responsibilities.
• Maintain accurate employee training plans, curricula, qualification records, and certification information.
• Administer and maintain the Learning Management System and associated training documentation in accordance with applicable procedures and record-retention requirements.
• Ensure that training documentation is accurate, current, readily available, and maintained in accordance with established procedures and applicable requirements.
• Provide supervisors and management with employee training, qualification, certification, and compliance status information.
• Conduct periodic training-system reviews and spot audits to verify compliance and identify opportunities for improvement.
• Assist with controlled-document distribution and documentation compliance for operational areas.
• Conduct or support investigations of nonconformances associated with the training system or potential human-error factors.
• Deliver orientation, induction, quality-system, and required site training to new employees.
• Support actions that ensure employees are appropriately trained and qualified before independently performing assigned responsibilities.