Vacancy expired!
DOCUMENT TRAINING COORDINATOR SUMMIT, NJ Project Description:
- The Training & Development Associate Specialist is responsible for the successful implementation of the site Manufacturing Training Program.
- They assist in determining training solutions that adhere to the Site Training Program.
- 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 Associate as needed.
- Implements training programs that meet regulatory requirements & business needs.
- 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.
- Works with the Manager on an on-going basis to implement training goals and meet KPI's.
- Conducts ILT and OJT sessions to ensure cleanroom 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.
- Collaborates with the Manager to ensure training is compliant and effective.
- Maintains accurate training documentation and employee record keeping.
- Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.
- Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
- Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.
- Develops / implements new course content as procedures change or as new techniques are introduced.
- 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.
- Promotes and exhibit core Celgene values in onboarding and training activities.
- Develops an on-the-job training schedule that accommodates individuals of various levels of experience and follows all regulatory and technical requirements.
- 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.
- Communicates with different departments to ensure new hires have access to all necessary systems and security.
- Maintains the training status of new hires and communicates progress to Department Management.
- Maintain the Training Laboratory and equipment for cleanliness and compliance.
- Complete room activity, maintenance, cleaning, and equipment usage logs (as required).
- Run daily calibration checks on equipment where appropriate and escalate deviations.
- Perform routine cleaning of laboratory areas and equipment.
- Ensure sufficient laboratory supplies for daily training activities.
- Manufacture clinical grade cellular therapeutic products to supply the Clinical Program (as needed).
- Execute/Implement batch records in ISO 7 & 8 clean room environments.
- Observe, practice, and promote all aspects of the GMP & GDP requirements.
- Complete and maintain aseptic processing and sterile gowning qualifications.
- 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 participate in follow up investigation when necessary.
- Performs all other duties as required.
- 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.
- Requires a high level of understanding of cell therapy processes, controls, and GMP requirements.
- Intermediate sills 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.
- 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.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
- The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
- There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
- Employees holding this position will be required to perform any other job-related duties as requested by management.
Vacancy expired!