GMP Training Specialist

Role Overview

• This position is the primary trainer for cGMP, cGDP, contamination control and aseptic behavior as it relates to aseptic manufacture of biologic products and materials
• Designs, develops and implements curricula, and conducts training for monoclonal antibodies drug product manufacturing, and biologics packaging in compliance with site procedures and global standards
• Identify and drive continuous process improvements related to GMP and aseptic training
• Continuously improve and innovate training execution and management, conducts audits/reviews of personnel to evaluate training effectiveness
• Makes decisions that are in accordance with company policies and SOPs, Core Values, and global regulatory guidelines (including cGMP/cGDP/cGLP), environmental guidelines
• Learning Management System administration (SAP SuccessFactors)
• Facilitate New Employee Orientation (including cGMP/cGDP/cGLP), and aseptic training for initial and refresher training for site personnel, including gowning qualification and classroom process simulations
• Coordinates required annual training requirements with department management
• Conducts spot checks/audits of aseptic techniques and behaviors during operations
• Observes aseptic process simulations (media fills) for aseptic practices and best practices
• Network with the Global Aseptic Team to share best practices
• Liaison with colleagues to ensure they are trained and understand the criticality of the aseptic process work they are conducting
• Coordinates personnel training using available technology, including, but not limited to, virtual reality technology
• Integrates training sessions and training documentation into electronic training document management systems
• Collaborate with area Operations Team Leaders to train and lead colleagues in the performance of best practices
• Collaborate with QC to analyze training techniques and instructions for error prone testing
• Collaborate with QA to analyze training techniques and instructions for incidents with patterns and trends
• Utilize subject matter knowledge related to Aseptic Processing in the conduct of training: GMP/Regulatory Requirements
• Compliance Trends and Data Integrity
• Basic Industrial Microbiology
• Types of Microorganisms
• Growth and Reproduction
• Sources of Cleanroom Contamination
• Reduction/Elimination
• Measurement Systems
• Site Specific Data Trends and Metrics Facility Design / Environmental Controls
• Cleaning and Disinfection (facility surfaces, equipment)
• Aseptic and Controlled Area Gowning
• Aseptic Training / Good Aseptic Technique
• Material Transfer
• Material/Personnel / Equipment Flow and Movement
• Use of Isolator and Barrier Systems
• Sterilization / Validation
• Bioburden Reduction

Requirements

• BS with 2-4 years of experience OR MS with 0-2 years of experience related to aseptic manufacturing
• Bachelor’s Degree in Engineering, Biology, Chemistry, Microbiology, Virology, Immunology, or related technical field
• Must have strong technical/analytical skills and possess a high degree of personal motivation
• Excellent interpersonal skills and ability to interact across divisional boundaries
• Familiar/proficient in adult learning methodologies
• Strong technical writing skills
• Preferred experience in aseptic and biological product formulation (blend/fill/lyophilization), packaging, and/or testing
• A working knowledge of vaccine production methods and experimental design and experience in GLP or cGMP
• Knowledge of FDA, APHIS, VMD, USDA regulations applicable to the Pharmaceutical/Biological industry
• Preferred experience in Lean/Six Sigma

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Professional development opportunities