GMP Training Lead

Zoetis; Lithia Springs (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

Zoetis in Lithia Springs, GA is seeking a GMP Training Lead to design, implement and manage cGMP and aseptic training for monoclonal antibody and biologics manufacturing. You will lead curriculum development and deliver training across startup-to-full-operations.

You will administer SAP SuccessFactors LMS, coordinate annual trainings, perform audits of aseptic techniques, and collaborate with QA, QC and Operations to ensure training effectiveness and regulatory compliance.

Qualifications

• Bachelor's degree required in Training & Development, Instructional Design, Adult Education, or related field.
• Minimum 5+ years of training delivery, coordination, curriculum development, or related functions.
• Experience with cGMP/cGDP/cGLP and aseptic training preferred.

Responsibilities

• LMS administration using SAP SuccessFactors.
• Facilitate new employee orientation and aseptic training for initial and refresher training.
• Coordinate annual training requirements with department management.
• Conduct audits of aseptic techniques and behaviors.
• Observe aseptic process simulations and share best practices with teams.
• Collaborate with QA, QC, and Operations to improve training effectiveness.

Skills

GMP Training

Curriculum Development

Training Delivery

Adult Learning

Interpersonal Skills

Technical Writing

Education

Bachelor's degree in Training & Development or related field

Tools

SAP SuccessFactors

Learning Management System (LMS)

Job description

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:

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.

Position 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

Education and Experience:

• Bachelor’s degree in Training & Development, Instructional Design, Adult Education, Organizational Development, Learning & Development, or Engineering, Biology, Chemistry, Microbiology, Virology, Immunology.
• Minimum of 5+ years of experience in training delivery, training coordination, curriculum development, learning and development, or related training functions, including demonstrated classroom facilitation and presentation experience.

Technical Skills Requirements:

• 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

Physical Requirements:

• 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
• Work Environment: While performing the duties of this job, the employee occasionally works in clean room environments. The noise of these work environments is typical office noise.