Trainer - Cell Culture Mfg
Edison-New Brunswick Metro Area, NJ
- Training Specialist is responsible for the successful implementation of the site Manufacturing Training Program.
- Assist in determining training solutions that adhere to the Site Training Program.
- This position may also perform cleanroom processing duties as a Manufacturing Associate as needed.
- Requires B.S.or MS 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.
Responsibilities will include, but are not limited to, the following:
Implements training programs that meet regulatory requirements & business needs including:
o Conducts training 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 Maintains accurate training documentation and employee record keeping.
o Develops course content and procedures including new SOPs, Training docs for manufacturing training programs as necessary.
o Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
Requires a high level of organizational and time management skills.
This position requires speaking in classroom settings.
Ability to work in an aseptic environment requiring successful completion of qualification program.
Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive standing.
Employees must work in areas where posted Universal Precautions must be observed and practiced.
Able to work independently, and in a team environment to complete routine tasks.
Must be flexible with work schedule as extended shift or weekend work may be required.