GMP Training Specialist

Zoetis•Atlanta, GA

About The Position

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 Specialist to join our team. Job Description: 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.

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.
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.
Must be able to walk or stand for long periods of time.
Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
Must be able to work scheduled 40 hours with the ability to work overtime as needed.
Frequent lifting and carrying of 5 to 25 lbs.
Regular reaching, bending, stooping, and twisting
Repetitive motion and substantial movement of the wrists, hands, and/or fingers
Able to become qualified to enter clean room environments

Nice To Haves

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

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: 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