GMP Training Lead

States considered: What is it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose ‘to nurture the world and humankind by advancing care for animals’ is what unites us in all our roles. We are a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than one hundred countries. And we are excited to become a part of the Lithia Springs, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.  We are currently searching for a GMP Training Lead to join our team.

Provide flexible training support across all identified functions, delivering startup-to-full-operations training and assuming responsibility for additional training needs as they arise.  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.

Responsibilities: •    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: o    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 o    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 Education and Experience: •    Bachelor’s degree in Training &