Manufacturing Training Associate
Edison-New Brunswick Metro Area, NJ
BS Biology, Micro, or related
Experienced in providing Training to lab associates for Environmental Monitoring / Aseptic Processing.
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 on an on-going basis to implement training goals and meet KPI s.
o Conducts training sessions to ensure cleanroom operators are proficient.
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.