B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 1-3 years relevant experience in a laboratory setting. Educational lab experience may be included in laboratory experience.
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.
Responsibilities will include, but are not limited to, the following:
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 company 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.
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.
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.
Able to work independently, and in a team environment to complete routine tasks.
Must be able to effectively communicate with Trainees, relevant Department Management, and other team members.
Must be flexible with work schedule as extended shift or weekend work may be required.
Responds to challenges and additional projects in an understanding, positive
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