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Document Training Coordinator

SUMMIT, NJ

Posted: 09/20/2022 Job Number: 21821627

Job Description

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.
Required Skills:
  • 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.

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.
  • 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.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-02709
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Bridget Burns

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