USA - Manufacturing Specialist - Abacus Service Corporation
Morris Plains, NJ 07950
About the Job
Description:
Onsite role Morris Plains, NJ site
Aseptic Trainer
This role is responsible for the technical training of manufacturing cell processors, media technicians, and other Cell and Gene Therapy support roles. This role provides support to the Aseptic Operations Training Program.
" Deliver on-the-job prerequisite training for Aseptic qualifications for skills such as micropipetting, aseptic gloving, aseptic gowning for cleanrooms, material sanitization, and operation of basic equipment (biosafety cabinet, tube welder, tube sealer).
" Deliver instructor-led and on-the-job training associated with Quality Systems and GMP Training requirements
" Conduct hands-on QC microbiology technical training for use of contact plates, active air monitoring devices, and non-viable particle monitoring devices.
" Demonstrate strong Aseptic Technique
" Demonstrate Good Documentation Practices
" Monitor and communicate real-time training gaps to Leads and Training team, and provide on-going feedback
" Maintain, evaluate and secure training records
" Ensure compliance to all relevant GxP and safety standards
" Ensure that all activities and documentation comply with the requirement of safety GDP/GMP Data Integrity standards
" Share knowledge and develop expertise of others and understanding of applied practice and processes in own area/discipline
" Ensure proper escalation of all matters related with HSE and quality
High school diploma with 1+ years of work experience in the GMP/pharmaceutical industry or equivalent. An advanced degree is desirable. 1+ years of related pharmaceutical technical training experience preferably in a production, QA, and/ or QC related role preferred. Direct experience working in a GMP and aseptic or sterile environment is desired. Aseptic gowning and clean room experience is highly desired. Cell & gene therapy experience highly desired.
Onsite role Morris Plains, NJ site
Aseptic Trainer
This role is responsible for the technical training of manufacturing cell processors, media technicians, and other Cell and Gene Therapy support roles. This role provides support to the Aseptic Operations Training Program.
" Deliver on-the-job prerequisite training for Aseptic qualifications for skills such as micropipetting, aseptic gloving, aseptic gowning for cleanrooms, material sanitization, and operation of basic equipment (biosafety cabinet, tube welder, tube sealer).
" Deliver instructor-led and on-the-job training associated with Quality Systems and GMP Training requirements
" Conduct hands-on QC microbiology technical training for use of contact plates, active air monitoring devices, and non-viable particle monitoring devices.
" Demonstrate strong Aseptic Technique
" Demonstrate Good Documentation Practices
" Monitor and communicate real-time training gaps to Leads and Training team, and provide on-going feedback
" Maintain, evaluate and secure training records
" Ensure compliance to all relevant GxP and safety standards
" Ensure that all activities and documentation comply with the requirement of safety GDP/GMP Data Integrity standards
" Share knowledge and develop expertise of others and understanding of applied practice and processes in own area/discipline
" Ensure proper escalation of all matters related with HSE and quality
High school diploma with 1+ years of work experience in the GMP/pharmaceutical industry or equivalent. An advanced degree is desirable. 1+ years of related pharmaceutical technical training experience preferably in a production, QA, and/ or QC related role preferred. Direct experience working in a GMP and aseptic or sterile environment is desired. Aseptic gowning and clean room experience is highly desired. Cell & gene therapy experience highly desired.
| Hours per Day | 7.5 |
|---|---|
| Hours per Week | 37.5 |
| Total Hours | 2,175.00 |
Source : Abacus Service Corporation