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Manufacturing Training Associate

Edison-New Brunswick Metro Area, NJ

Posted: 09/13/2019 Job Type: Scientific Job Number: JN -092019-25609

Job Description

JOB DESCRIPTION:

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.


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