Primary Talent Partners is seeking a training and Development Specialist in the Summit, NJ area. This role will be a 12 month, full-time contract role with high potential to extend and/or convert. The role is 100% on-site so only local candidates are being considered at this time.
Pay: $30 - $34.50/hr based upon experience.
Job Details:
This position trains other staff members, as well as assesses their ability to perform tasks proficiently. This position may also perform cleanroom processing duties as a Manufacturing Operator as needed.
- Implements training programs that meet regulatory requirements & business needs including:
- Conducts ILT and OJT sessions to ensure cleanroom/manufacturing operators are proficient.
- Provides feedback to trainees to ensure all skills/knowledge have been acquired and communicates any skill/knowledge gaps that require additional training.
- Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities.
- Maintains accurate training documentation and employee record keeping.
- Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
- Implements the local Breyanzi Manufacturing Operations Training Program including:
- Promotes and exhibit core Client values in training activities.
- Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
- Conducts ITL/OJT structured trainings for new hires to introduce to aseptic processing and GMP space, and process training.
- Maintains the training status of new hires and communicates progress to Department Management.
- Maintains the Training Laboratory and equipment for cleanliness and compliance.
- Completes room activity, maintenance, cleaning, and equipment usage logs (as required).
- Runs daily calibration checks on equipment where appropriate and escalates deviations to area management.
- Performs routine cleaning of laboratory areas and equipment.
- Ensures sufficient laboratory supplies for daily training activities.
- Maintains training area organized according to 5S principles.
- Routinely participates in processing of cellular therapeutic products on the shop floor (as needed):
- Executes/Implements batch records in clean room environments.
- Observes, practices, and promotes all aspects of the GMP & GDocP requirements.
- Completes and maintains aseptic processing and sterile gowning qualifications.
- Communicates with Quality Control to ensure proper handoff of process samples.
- Reports and initiates non-conformances and participates in follow up investigation when necessary.
- Performs all other duties as required.
- Requires a high level of understanding of cell therapy processes, controls, and GMP requirements.
- Intermediate skills in implementation of training.
- Advanced skills in using Microsoft Word, PowerPoint and Excel.
- Requires a high level of organizational and time management skills.
- Ability to communicate information clearly to facilitate effective learning. This position requires speaking in classroom settings.
- Requires strong interpersonal skills which enable appropriate collaboration with trainees, colleagues, and subject-matter experts.
- Ability to work in an aseptic environment requiring successful completion of aseptic qualification program.
- 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.
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