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Learning and Development Specialist
1 month ago
Location: Devans, MA
Hours/Schedule: Mon - Fri, Business Hours
Type: Contract
Join a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients with serious ..
Responsibilities
- Implements training programs that meet regulatory requirements & business needs.
- Provide 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 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 support functional unit training requirements.
- 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 L&D team and functional SMEs 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.
- Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
- Communicates with different departments to ensure new hires have access to all necessary systems and security.
- Observe, practice, and promote all aspects of the GMP & GDP requirements.
- 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.
Knowledge, Skills, and Abilities:
- Requires understanding of GMP manufacturing environments, processes and controls requirements.
- Intermediate sills 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.
- 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.
- Bachelor degree in Business or Education, B.S. in Biology, Biochemical, Chemical, or 3-5 years of relevant experience in a GMP manufacturing environment.
Benefits
System One offers eligible employees 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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