Manufacturing Training Associate
Edison-New Brunswick Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
Implements training programs that meet regulatory requirements & business needs including:
o Works with the Manager to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion.
o Works with the Manager on an on-going basis to implement training goals and meet KPI s.
o Conducts ILT and OJT sessions to ensure cleanroom operators are proficient.
o Provides feedback to trainees to ensure all skills / knowledge have been acquired and communicates any skill/knowledge gaps that require additional training.
o Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities.
o Collaborates with the Manager to ensure training is compliant and effective.
o Maintains accurate training documentation and employee record keeping.
o Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.
o Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
o Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.
o Develops / implements new course content as procedures change or as new techniques are introduced.
o Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
KNOWLEDGE/SKILLS/ABILITIES (KSA s):
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.
One year in a GMP environment, minimum.
Able to work in clean-room environment (including gowning-in, no makeup / no perfume / no hairspray, plus other clean room requirements). Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps
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.