- Where
- Greenville, North Carolina, USA
- Level
- Senior
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job Description
Company Information
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
Group/Division Summary
The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
Position Summary
The Steriles University Training Specialist III is responsible for supporting the development and delivery of the required introductory cGMP Steriles Manufacturing and Device Assembly Manufacturing Training for all new hires that will work in Steriles Manufacturing and Device Assembly Manufacturing environments utilizing a customized Virtual Reality program, instructor led training, and the Thermo Fisher Scientific's Learning Management System (LMS) ensuring compliance to regulatory agency regulations and procedural requirements. This position is responsible for supporting and continuously improving the Steriles University Training Program by working directly with all levels of Steriles Manufacturing and Device Assembly Manufacturing leadership staff to establish assignment profiles and curriculums based on assigned roles and functions.
Key Responsibilities:
Facilitate Steriles University classroom training including new hire and annual training.
Manage the design and development, classroom, eLearning, and On the Job Training (OJT) material based on user requirements.
Maintain up-to-date knowledge of industry and regulatory trends to ensure system remains compliant with stated expectations and best practices.
Manage semi-annual review with Steriles Leadership/Management of new and existing training materials to ensure proper transfer of knowledge to trainees and the organizations readiness to meet company objectives and growth.
Maintain all Steriles University support systems.
Host corporate, customer, and/or educational site tours of the Training Center.
Supports new hire orientation event
Leads projects and training initiatives that drive quality, compliance and operational effectiveness for the organization
Maintain consistent communication with network counterparts for best practice sharing
Deploys the use of professional documentation and training development authoring tools to aide in the building and maintenance of instructional modules.
Administers training assessments to evaluate the progress of the trainee and identify any learning gaps that require further training.
As a process SME that maintains a detailed knowledge, ensure SU Training team is aware of the training process history, compliance, operations, changes, and deviating events.
Assists with evaluations of the effectiveness of training programs…