Steriles University Training Specialist III

Thermo Fisher Scientific•Greenville, NC

3d•Onsite

About The Position

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.

Requirements

Must be Legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check to include drug screening.
Associates degree in Education, Business, Technical discipline, or related field with 7+ years of experience in cGMP steriles manufacturing and/or device assembly manufacturing environments, LMS systems, and training experience required.
Requires a high level of understanding of steriles manufacturing and device assembly manufacturing processes, controls, and GMP requirements, so 7+ years of steriles manufacturing and/or device assembly manufacturing technical experience in at least 3 process areas is strongly preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Advanced understanding of training, instructional design, communication and/or education.
Advanced functional and process knowledge to support the integrated design and development of training programs.
Advanced coaching ability to support a variety of learning styles and approaches when delivering training to adult learners.
Excellent verbal, written, and interpersonal communication skills
Strong speaking and presentation skills
Strong interpersonal and relationship building skills
Strong commitment to customer service training
Strong proficiency with computer operating systems and software skills (i.e. Microsoft Office applications, LMS,...)
Advanced project and time management skills
Must be skilled in decision-making, building relationships, problem solving, planning, and organizing.
Must be able to work independently.
Understanding of distribution process along with awareness of regulatory documentation requirements.
Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
Ability to lead cross-functional project teams.

Nice To Haves

Bachelor's degree in Education, Business, Technical discipline, or related field with 5+ years of experience in cGMP steriles manufacturing and/or device assembly manufacturing environments, LMS systems, and training experience preferred.

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 and learning outcomes.
Documents and provides reports on progress of training outcomes to management.
Partners with Device Assembly Manufacturing Subject Matter Experts to develop training materials and provide guidance in the development and implementation of a consistent training program.
Partners with Steriles Operations Subject Matter Experts to develop training materials and provide guidance in development and implementation of a consistent training program.
Complies with all job-related safety and other training requirements.
Work in a safe and responsible manner to create an injury-free and incident free workplace.
Performs other duties as assigned