PURPOSE AND SCOPE OF POSITION :
The Training & Development Specialist is responsible for the successful implementation of the Devens site Training Program. The Specialist assists in determining training solutions that support strict performance and quality standards. This position trains other staff members, as well as assesses their ability to perform tasks proficiently. The Specialist may train in manufacturing spaces which may require the use of safety and personal protection clothing and footwear.
REQUIRED COMPETENCIES :
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 qualificationprogram.Education and Experience :
Bachelor degree in Business or Education, B.S. in Biology, Biochemical, Chemical, or 3-5 years of relevantexperience in a GMP manufacturing environment.
DUTIES AND 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 addressproduction 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 anyskill / knowledge gaps that require additional training.
Solicits feedback from trainees to ensure the appropriateness of course content, and for continuousimprovement 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 continuousimprovement.
Develops course content and procedures including new SOPs, TRNs for manufacturing training programs asnecessary.
Collaborates with L&D team and functional SMEs to identify trends which may require amendment to trainingprograms.
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 trainingare continuously applied.
Implements the local Manufacturing Operations new hire Training Program.Promotes and exhibit core Client values in onboarding and training activities.Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinatingenrollment, 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 ofchanges by utilizing quality systems.
Reports and initiates non-conformances and participates in follow up investigation when necessary.Performs all other duties as required.
