Position Overview

The Training Lead operates with minimal supervision, providing essential support to the Invivo Operations department by developing, coordinating, and ensuring adherence to GLP-compliant training procedures and practices. This role, as delegated by department management, is responsible for overseeing the successful execution of training activities and the maintenance of technical skills. The Training Lead will offer administrative and organizational assistance in planning, scheduling, coordinating training sessions, managing documents, and reporting. Responsibilities also include performing quality control (QC) and maintaining plans, SOPs, worksheets, raw data, study binders, and data archiving. Additionally, support may be provided to other workgroups as required.

Key Responsibilities

• Develop and implement Standard Operating Procedures and qualification criteria to ensure compliance with FDA (GLP), L&I, and other regulatory bodies.
• Research and train staff on new procedures, overseeing their implementation.
• Collaborate with department trainers and management to schedule training and cross-training sessions.
• Provide training and cross-training on the technical execution of current protocols, SOPs, and daily activities within the department and related services.
• Identify and support trainer staff, ensuring consistent training content across the team.
• Lead the development and maintenance of training programs and assist with the creation and upkeep of training forms or electronic records.
• Focus on process management and standardization to enhance efficiency and quality.
• Ensure proper documentation of training procedures and data acquisition to accurately reflect compliance with plans, SOPs, and protocols while addressing the needs of department management.
• Collaborate with all groups to refine processes.
• Monitor and communicate training deadlines to guarantee adherence to established schedules.
• Inform study personnel and department management of training deadlines.
• Track milestones and keep training schedules current.
• Manage the timely review and organization of training documentation.
• Assign and supervise staff duties necessary for achieving training objectives.
• Conduct hands-on training for staff on classes and technical skills, assessing competency.
• Address Quality Assurance audits concerning training processes and corrective actions that necessitate training.
• Perform QC reviews of data promptly.

Qualifications

• Bachelor's degree in biological sciences or a related field.
• Relevant laboratory experience and administrative skills may substitute for educational qualifications.
• A minimum of 1 year of experience as a trainer is required; 3 years of experience in a research or regulated environment is preferred.
• Professional certification in a relevant area (e.g., AALAS, ASCP) is preferred.
• Proficiency in Microsoft Word, Excel, Project, InfoPath, Access, Outlook, and PowerPoint, with the ability to adapt to new software programs easily.
• Strong language skills, including proficiency in written and verbal English, with the ability to read and interpret safety rules, operating and maintenance instructions, software manuals, study documents, and procedure manuals; capable of writing routine reports and correspondence and effectively communicating with various stakeholders.
• Strong math skills, including the ability to understand and utilize mathematical concepts for calculating and interpreting scientific data.
• Ongoing GLP training and familiarity with relevant procedures and SOPs within the department.
• Ability to work cross-functionally on process improvements.
• Proficient problem-solving skills, capable of addressing various practical challenges; ability to interpret diverse instructions presented in written, oral, diagrammatic, or scheduled formats, demonstrating keen attention to detail.

Medix is acting as an Employment Agency in relation to this vacancy.