Newark Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
Implements training programs that meet regulatory requirements & business needs including:
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 Maintains accurate training documentation and employee record keeping.
o Develops course content and procedures including new SOPs, TRNs 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.
o Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
o Conducts ITL/OJT structured trainings for new hires to introduce to aseptic processing and GMP space, and process training.
Maintain the Training Laboratory and equipment for cleanliness and compliance.
o Perform routine cleaning of laboratory areas and equipment.
o Ensure sufficient laboratory supplies for daily training activities.
o Observe, practice, and promote all aspects of the GMP & GDP requirements.
o Complete and maintain aseptic processing and sterile gowning qualifications.
Performs all other duties as required.
Requires a high level of understanding of cell therapy processes, controls, and GMP requirements.
Must be able to create PowerPoint presentations and perform data entry in Excel
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.
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.