Quality Specialist III - Learning & Development

Thermo Fisher Scientific•Greenville, NC
•Onsite

About The Position

As part of Thermo Fisher Scientific’s Drug Product Division, this position supports sterile pharmaceutical manufacturing at the Greenville, North Carolina site. The role is part of the Quality Assurance Training and Development team and works with Manufacturing, Quality, Engineering, and other technical partners to develop employee capabilities, operational performance, and regulatory compliance. The Operations Training Specialist III combines hands-on instruction with instructional design and development, with approximately 50% of the role devoted to each. The specialist participates in a structured new-employee training program and develops learning solutions for manufacturing processes, equipment, and technologies. Working with subject matter experts and operational teams, the role translates technical information into practical and engaging learning experiences. The position is based on-site at a pharmaceutical manufacturing facility. Work includes classroom instruction, computer-based training development, collaboration with operational teams, and periodic visits to manufacturing areas. Employees must follow applicable safety, gowning, and site-access requirements in controlled environments. Routine business travel is not anticipated.

Requirements

  • Strong understanding of adult learning principles and ability to deliver engaging, effective instruction.
  • Excellent analytical, problem-solving, communication, and interpersonal skills.
  • Knowledge of aseptic gowning practices in sterile or controlled manufacturing environments.
  • Ability to translate technical information into clear training materials, practical exercises, and learner assessments.
  • Proficiency with Microsoft Office and ability to develop computer-based learning materials.
  • Strong organizational and project coordination skills, with ability to manage multiple priorities independently and collaboratively.
  • Ability to engage effectively with manufacturing employees, technical experts, and cross-functional stakeholders.
  • Ability to stand during training sessions, move throughout the facility, and operate computers and audiovisual equipment.
  • Ability to follow applicable safety, gowning, and site-access requirements when entering controlled environments.

Nice To Haves

  • Bachelor’s degree in Education, Instructional Design, Business, Life Sciences, Engineering, or a related field is preferred.
  • An associate degree with relevant manufacturing, training, or operational experience may be considered.
  • Candidates without a college degree may be considered if they demonstrate substantial relevant experience and strong instructional capabilities, subject to applicable job qualification requirements.
  • Experience in training, learning and development, instructional design, pharmaceutical manufacturing, sterile operations, or another regulated manufacturing environment is preferred.
  • Hands-on manufacturing experience with training, coaching, or qualifying colleagues is relevant; formal classroom instruction experience is beneficial but not required for candidates with strong communication skills and ability to develop effective learning materials.
  • Familiarity with cGMP requirements, quality systems, and regulated manufacturing practices is preferred.
  • Experience with instructional design tools such as Articulate, Adobe Creative Cloud, Captivate, or similar platforms is preferred.
  • Experience with eLearning, multimedia development, learning management systems, or immersive learning technologies is a plus.

Responsibilities

  • Deliver instructor-led training within a structured four-week onboarding program covering approximately 30 operational courses.
  • Develop proficiency across the training curriculum and facilitate classroom, hands-on, and individualized learning experiences.
  • Design and develop training materials for manufacturing processes, equipment, technologies, and operational procedures.
  • Partner with subject matter experts and Manufacturing, Engineering, Validation, and Quality teams to translate technical information into effective learning solutions.
  • Create interactive training content, including eLearning, videos, presentations, simulations, practical exercises, and proficiency assessments.
  • Evaluate training effectiveness, provide coaching and targeted retraining, and continuously improve learning outcomes.
  • Coordinate training development projects, managing stakeholders, priorities, timelines, and deliverables.
  • Maintain accurate training documentation and ensure alignment with cGMP requirements, quality systems, and established procedures.
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