Job Description

About the Role

Works under limited supervision and supports the department by providing the development, coordination, and assurance of GLP compliant training procedures and practices. Works, as delegated by department management, to ensure the successful completion of training activities and maintenance of technical skills. Provides administrative and organizational support in training planning, scheduling, coordination, document management and reporting. Performs quality control (QC) and/or maintenance of plans, SOPs, worksheets, raw data, study binders, and data archiving. May provide support for other work groups as needed.

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

What You’ll Need to Succeed

• BA/BS in biological sciences or related science degree; education may be substituted with related laboratory experience and administrative skills
• 2+ years working in a vivarium setting required
• 1+ years staff training experience required
• 3+ years working in a research or regulated environment preferred
• Professional certification in area of expertise preferred
• Intermediate computer skills including proficiency with Microsoft Office suite
• English proficiency both written and verbal; general reading, writing and verbal communication skills
• Intermediate maths skills
• Ability to work cross functionally on process improvements
• Practical problem solving skills and can deal with a variety of concrete variables
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Demonstrate attention to detail

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