System One - Devens, MA

posted about 1 month ago

Full-time - Entry Level
Devens, MA
Administrative and Support Services

About the position

The Learning & Development Specialist plays a crucial role in a global biopharmaceutical company by designing, implementing, and assessing training programs that meet regulatory requirements and business needs. This position focuses on ensuring that new hires become proficient operators in a GMP manufacturing environment, facilitating effective learning through various training methods, and collaborating with subject matter experts to continuously improve training content and delivery.

Responsibilities

  • Implements training programs that meet regulatory requirements & business needs.
  • Provides training expertise and consultation in support of the Devens site training model and process.
  • Works with L&D and functional Subject Matter Experts to create a training and development plan to address production demands.
  • Conducts ILT and OJT sessions to support functional unit training requirements.
  • Provides feedback to trainees to ensure all skills/knowledge have been acquired.
  • Solicits feedback from trainees to ensure the appropriateness of course content.
  • 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.
  • Develops course content and procedures including new SOPs, TRNs for manufacturing training programs.
  • Performs competency assessments of operators on an ongoing basis.
  • Implements the local Manufacturing Operations new hire Training Program.
  • Performs administrative tasks such as scheduling training sessions and coordinating enrollment.
  • Communicates with different departments to ensure new hires have access to all necessary systems and security.
  • Observes, practices, and promotes all aspects of the GMP & GDP requirements.
  • Reports and initiates non-conformances and participates in follow-up investigations.

Requirements

  • Bachelor degree in Business or Education, B.S. in Biology, Biochemical, Chemical, or 3-5 years of relevant experience in a GMP manufacturing environment.
  • Requires understanding of GMP manufacturing environments, processes and controls requirements.
  • Intermediate skills in design, development, and implementation of training, utilizing ADDIE instructional design model.
  • High level of experience delivering and assessing 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.
  • Requires strong interpersonal skills for collaboration with trainees, colleagues, and subject-matter experts.

Benefits

  • Health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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