GMP Training Lead

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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. Job Description: This position is the process owner for GMP training at the site. The lead will develop and deliver cGMP and cGDP training, as well as support training development regarding contamination control and aseptic behavior as they relate to aseptic manufacture, filling, and packaging of biological and biopharma drug products. Designs, develops, implements curricula, and conducts training 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, conduct 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. Position Responsibility: Provide flexible training support across all identified functions, delivering startup-to-full-operations training and assuming responsibility for additional training needs as they arise. 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 training and understanding of the critical aseptic processing that 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 drug product manufacturing, filling, and packaging in the development 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 Education and Experience: BS (minimum) with 8+ years of experience related to pharmaceutical manufacturing and packaging. 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 people skills and ability to interact across divisional boundaries. Technical Skills Requirements: Strong technical/analytical skills and possess a high degree of personal motivation. Strong presentation and presentation development skills. Excellent people skills and ability to interact across divisional boundaries. Familiar/proficient in adult learning methodologies. Strong technical writing skills. Working knowledge of pharmaceutical production methods and cGMP experience. Knowledge of FDA, APHIS, VMD, USDA regulations applicable to the Pharmaceutical/Biological industry. Preferred experience in aseptic and biological product formulation (blend/fill/lyophilization), packaging, and/or testing. Preferred experience in Lean/Six Sigma. Physical Requirements: Able to walk or stand for extended periods of time. Able to reach above shoulder level, bend/stoop, kneel,

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