Job Details

  • Title: Training Development Specialist
  • Code: RCI-35969-1
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 02/25/2021
  • Duration: 6 Months

  Job Description


  • B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 1-3 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.
  • Requires a high level of understanding of cell therapy processes, controls, and GMP requirements.
  • Intermediate sills in design, development, and implementation of training.
  • Advanced skills in using Microsoft Word, PowerPoint and Excel.
  • Requires a high level of organizational and time management skills.
  • Ability to communicate information clearly to facilitate effective learning. This position requires speaking in classroom settings.
  • Requires strong interpersonal skills which enable appropriate collaboration with trainees, colleagues, and subject-matter experts.
  • Ability to work in an aseptic environment requiring successful completion of qualification program.
  • Implements training programs that meet regulatory requirements & business needs including:
    • Works with the Manager to create a training and development plan to deploy training across site as it relates to Quality Systems in a timely fashion.
    • Works with the Manager on an on-going basis to implement training goals and meet KPI’s.
    • Conducts ILT and OJT sessions to ensure employees are proficient.
    • Provides feedback to trainees to ensure all skills / knowledge have been acquired and communicates any skill/knowledge gaps that require additional training.
    • Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities.
    • Collaborates with the Manager to ensure training is compliant and effective.
    • Maintains accurate training documentation and employee record keeping.
    • Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.
    • Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
    • Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.
    • Develops / implements new course content as procedures change or as new techniques are introduced.
    • Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
  • Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.
  • Performs all other duties as required.