Zoetis

GMP Training Specialist

Zoetis

full-time

Posted on:

Location Type: Office

Location: Lithia Springs • United States

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About the role

  • 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
  • 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

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
  • 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
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
aseptic manufacturingcGMPcGDPcGLPadult learning methodologiestechnical writingbiological product formulationLeanSix Sigmaexperimental design
Soft Skills
technical skillsanalytical skillspersonal motivationinterpersonal skillscollaborationcommunicationtraining executionprocess improvementauditingleadership