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Validation Training Specialist

Summit, NJ

Posted: 01/20/2023 Job Number: 22912070

Job Description

VALIDATION TRAINING SPECIALIST
SUMMIT, NJ
Specialist, Instructional Design & Systems Training, Cell Therapy Business Process Management.

Required Skills:
  • Strong experience and knowledge of GxP and applicable Health Authority regulations / guidelines and industry best practices for supporting a training program.
  • Strong communication skills with clients to identify the learning goals for the training projects.
  • Strong experience and thorough understanding of global regulatory training requirements.
  • Strong experience and an in-depth knowledge of adult learning principles.
  • High level of understanding of systems, computer system validation, and GxP requirements.
  • Capable of leading and working cross-functionally to support the training requirements associated with Cell Therapy Business Process Management activities.
  • Proven experience working as a detailed oriented team player with effective planning, organization, and execution skills.
  • Innovative, proactive, and resourceful, committed to quality and continuous improvement.
  • Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
  • Effective manager of project deliverables.
  • Able to manage multiple priorities.
  • Experience with Success Factors and Articulate preferred.
  • Strong project planning skills.
  • Strong computer skills with MS Office (e.G., Word, Visio, and Excel) and with Quality Systems (e.G., Document Management System, Quality Management System) and learning management systems (Success Factors).

Project Description:
  • The primary focus for this role is to lead and manage the instructional design, the training development for instructor-led, on-the-job, and computer-based training courses that support the Business Process Management portfolio of projects.
  • This role is also responsible for the successful implementation of systems training including but not limited to Oracle and SAP.
  • This role also entails end-to-end training design, development & deployment activities in support of Cell Therapy, Business Process Management Portfolio.
  • This role will provide coaching on training requirements, adult learning principles, curricula design support and alignment to local training processes and with global and / or regulatory requirements.
  • Support, maintain, encourage, engage, and empower a learning culture for trainees and for the BPM Training and Organizational Change Management Team.
  • Oversee learning and performance enhancement programs from start to finish.
  • Act as an effective change agent.
  • Design, Develop and Deploy the learning and performance enhancement experience.
  • Manage competing priorities and work within a team to drive completion of projects.
  • Develop training KPIs that measure the effectiveness of training programs, return on investments and support business goals and objectives.
  • Align, coach, and develop training programs that drive an increase in overall training effectiveness and the empowerment Cell Therapy personnel.
  • Design and develop training courses using various instructional design methodologies while incorporating adult learning principles.
  • Contribute to the writing, review, approval and maintenance of metrics, and associated training Standard Operating Procedures (SOPs) or Work Procedures (WP).
  • Identify, evaluate, and implement key performance metrics for training effectiveness and for business expectations regarding training design.
  • Analyze training effectiveness data and lead improvement training and learning initiatives.
  • Create engaging learning activities and compelling course content.
  • Work with Subject Matter Experts to identify target audience' s training needs.
  • Set instructional end goals and create content that matches them.
  • Visualize instructional graphics, the user interface, and the finished product.
  • Create supporting materials/media (audio, video, simulations, role plays, games, etc.).
  • Devise modes of assessments, such as tests, quizzes, to measure the effectiveness of the course.
  • Maintain and control electronic document content and folders as per good documentation requirements.
  • Drive continuous improvement for training programs.
  • Address recurring issues identified for training.
  • Provide coaching and guidance for training programs that support integration and implementation of new products and/or processes.
  • Ensure training documentation/files are maintained, with good documentation practices and in compliance with Quality Systems and retention programs.
  • Work independently and perform with a high degree of accuracy.
  • Partner with other members the Cell Therapy Operations Training Team and other training teams across the organization to build harmony and alignment.
  • Support internal and external Audits/Inspections.
  • Develop Key Performance indicators to display the effectiveness of training programs, the instructional design capacity and delivery output, etc.
  • Meet and display client' s Values in all interactions.
  • Identify stakeholders and work closely with them to define current training and layout the plan for envisioned training design, development, and deployment.
  • Collect the necessary data points to map current training/performance pain points and translate them in corrective learning experience with training effectiveness embedded into the learning & performance enhancement experience.
  • Instructional design experience incorporating adult learning principles and SMART training objectives.
  • Design & Analyze learning & performance management techniques to measure the effectiveness of the learning & performance experience.

This 12+ month position starts ASAP.

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

ALPHA' S REQUIREMENT #23-00172
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Jim Pizzelanti

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