The Training Lead works under limited supervision and supports the In vivo Operations 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
Develops and implements Standard Operating Procedures and qualification requirements, ensuring compliance with FDA (GLP), L&I, and other regulatory agencies
Researches new procedures, trains and oversees their implementation
Coordinates with department trainers and management to schedule training and cross training
Trains and cross trains 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
Helps identify trainer staff and ensures uniform training content across all trainer staff
Is responsible for the development and maintenance of training programs, and may assist with the creation and maintenance of training forms or electronic records
Focuses on process management and standardization to improve efficiency and quality
Determines 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
Works with all groups to improve processes
Monitors and communicates training deadlines to ensure adherence to set schedules
Communicates training deadlines to study personnel and department management
Tracks milestones and ensures training schedules are up to date
Manages the timely review and assembly of training documentation
Assigns and oversees duties to personnel necessary to complete training objectives
Provides hands-on training of staff for classes and technical skills, and assesses competency
Responds to Quality Assurance audits for training processes and corrective actions that require training
Performs QC review of data in a timely manner
What You'll Need to Succeed
Bachelor's of Science degree (BS), specializing in biological sciences or related science degree
Equivalent laboratory experience and administrative skills fundamental for this job may be substituted for educational requirement
At least 1 year working in as a trainer required; 3 years experience working in a research and/or regulated environment preferred
Professional certification in area of expertise preferred (e.g., AALAS, ASCP)
The ability to work with Microsoft Word, Excel, Project, Info Path, Access, Outlook, and PowerPoint. Able to adapt easily to new software programs
The language skills required include, but are not limited to, proficiency in both written and verbal English, the ability to read and interpret documents such as safety rules, operating and maintenance instructions, software manuals, study documents, and procedure manuals; the ability to write routine reports and correspondence; and the ability to effectively communicate information and respond to questions from other departmental directors/managers, Study Directors, clients, potential customers, and the general public
The math skills required include, but are not limited to: the ability to understand and utilize appropriate mathematical concepts for calculating and interpreting scientific data
Continual GLP training and training on applicable procedures and SOPs within the department
Ability to work cross functionally on process improvements
Ability to solve practical problems and deal with a variety of concrete variables; the ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form; and demonstrates attention to detail