What You’ll Do Here
• Develop and implement Standard Operating Procedures and qualification requirements, ensuring compliance with FDA (GLP), L&I, and other regulatory agencies
• Research new procedures, train and oversee their implementation
• Coordinate with department trainers and management to schedule training and cross training
• Train and cross train in the technical execution of current protocols and standard operating procedures (SOPs), daily activities associated with all functions of the department and other related services
• Help identify training staff and ensures uniform training content across all trainer staff
• Responsible for the development and maintenance of training programs and may assist with the creation and maintenance of training forms or electronic records
• Focus on process management and standardization to improve efficiency and quality
• Determine proper documentation of training procedures and data acquisition in an effort to accurately document compliance with plans, SOPs and Protocols while facilitating the needs of department management
• Work with all groups to improve processes
• Monitor and communicate training deadlines to ensure adherence to set schedules
• Communicate training deadlines to study personnel and department management
• Track milestones and ensure training schedules are up to date
• Manage the timely review and assembly of training documentation
• Assign and oversee duties to personnel necessary to complete training objectives
• Provide hands-on training of staff for classes and technical skills, and assesses competency
• Respond to Quality Assurance audits for training processes and corrective actions that require training
• Perform QC review of data in a timely manner
• Work with different departments to help ensure consistency of training practices and organization
• Support and participate in study procedures if necessitated by workload
• Supervise studies, procedures and research assignments and coordinate duties of personnel and study teams
• Participate in evaluation, performance or maintenance of new systems or equipment
• Maintain general organization and cleanliness of work area, including cleaning and disinfecting procedure rooms and preparation areas