Manufacturing - Training & Development Specialist

Manufacturing Training Specialist

100% onsite

PURPOSE AND SCOPE OF POSITION:
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.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

• 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.

Education and Experience:

• 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.

DUTIES AND RESPONSIBILITIES:

• 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 escalate 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.

Lab w/ blood & animal Position Handles Hazardous Material

WORKING CONDITIONS:

Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials. Frequent visual demands require macroscopic and microscopic observations. Employees must work in areas where posted Universal Precautions must be observed and practiced. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.