Our client, a leading pharmaceutical company, is hiring a Document Training Coordinator on a contract basis.
• Requires a high level of understanding of cell therapy processes, controls, and GMP requirements.
• Intermediate skills in design, development, and 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 qualification program.
Education and Experience
• Preferred B.S. or Associate degree 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:
o Works with the Manager to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion.
o Works with the Manager on an on-going basis to implement training goals and meet KPIs.
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 Collaborates with the Manager to ensure training is compliant and effective.
o Maintains accurate training documentation and employee record keeping.
o Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.
o Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
o Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.
o Develops / implements new course content as procedures change or as new techniques are introduced.
o Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
• Implements the local Manufacturing Operations new hire Training Program including:
o Promotes and exhibit core Celgene values in onboarding and training activities.
o Develops an on-the-job training schedule that accommodates individuals of various levels of experience and follows all regulatory and technical requirements.
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.
o Communicates with different departments to ensure new hires have access to all necessary systems and security.
o Maintains the training status of new hires and communicates progress to Department Management.
• Maintain the Training Laboratory and equipment for cleanliness and compliance.
o Complete room activity, maintenance, cleaning, and equipment usage logs (as required).
o Run daily calibration checks on equipment where appropriate and escalate deviations.
o Perform routine cleaning of laboratory areas and equipment.
o Ensure sufficient laboratory supplies for daily training activities.
• Manufacture clinical grade cellular therapeutic products to supply the Clinical Program (as needed):
o Execute/Implement batch records in ISO 7 & 8 clean room environments.
o Observe, practice, and promote all aspects of the GMP & GDP requirements.
o Complete and maintain aseptic processing and sterile gowning qualifications.
o Communicate with Quality Control to ensure proper handoff of process samples.
• Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.
• Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.
• Reports and initiates non-conformances and participates in follow up investigation when necessary.
• Performs all other duties as required.