GMP Training Lead

Zoetis • Atlanta, GA

2d • Onsite

About The Position

Zoetis is the world leader in animal health, dedicated to serving veterinarians, livestock producers, and people who raise and care for farm and companion animals in over 100 countries. We are building a new manufacturing facility in Lithia Springs, GA, to support our growing monoclonal antibody and vaccine portfolios. We are currently seeking a GMP Training Lead to join our team. 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. The role involves designing, developing, and implementing curricula, and conducting training in compliance with site procedures and global standards. The lead will also identify and drive continuous process improvements related to GMP and aseptic training, and continuously improve and innovate training execution and management. Audits and reviews of personnel will be conducted to evaluate training effectiveness. Decisions made will be in accordance with company policies and SOPs, Core Values, and global regulatory guidelines (including cGMP/cGDP/cGLP) and environmental guidelines.

Requirements

• 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.
• Strong technical/analytical skills and possess a high degree of personal motivation.
• 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.
• Able to walk or stand for extended periods of time.
• Able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
• 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 environment.

Nice To Haves

• Preferred experience in aseptic and biological product formulation (blend/fill/lyophilization), packaging, and/or testing.
• Preferred experience in Lean/Six Sigma.

Responsibilities

• Provide flexible training support across all identified functions, delivering startup-to-full-operations training and assuming responsibility for additional training needs as they arise.
• 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.
• Coordinate required annual training requirements with department management.
• Conduct spot checks/audits of aseptic techniques and behaviors during operations.
• Observe aseptic process simulations (media fills) for aseptic practices and best practices.
• Network with the Global Aseptic Team to share best practices.
• Liaise with colleagues to ensure training and understanding of the critical aseptic processing that they are conducting.
• Coordinate personnel training using available technology, including virtual reality technology.
• Integrate 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, including 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, 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, and Bioburden Reduction.

Benefits

• Competitive healthcare and retirement savings benefits
• An array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior