Principle Training Analyst , QA/QC

Novo Nordisk-posted 9 months ago
Mid Level
Bloomington, IN
Chemical Manufacturing
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At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

  • Develop and deliver effective training programs to support business objectives, improve human performance, and ensure compliance.
  • Collaborate with business areas to develop training strategies that support daily operations and expansion projects for operational readiness.
  • Evaluate the effectiveness of training programs and make recommendations for improvement.
  • Work closely with business function areas to deliver comprehensive 'On the Job' training programs that enable excellence in the execution of manufacturing processes and quality systems.
  • Implement training systems, ensuring that all training solutions are simple, effective, and meet the needs of our employees.
  • Responsible for effective delivery of cGMP and other regulatory training, facilitating the transition of new hires from training to the work environment.
  • Maintain training processes and systems to ensure inspection readiness related to training.
  • Identify internal and external training programs to address competency gaps.
  • Apply adult learning and instructional design in the development and delivery of training modules in specialized technical and GMP topics.
  • Review and approve business function SOPs for training impact; recommend appropriate training methodology for knowledge transfer and effective learning outcomes.
  • Coordinate training and communication with SOP and process implementation.
  • Design and apply assessment tools to measure training effectiveness.
  • Coach and develop SME/certified trainers.
  • Participate in deviation reduction management programs; assist in review of 'human error'-related incidents to determine need for additional training interventions.
  • Support regulatory and client inspections as an SME for Training Systems.
  • Manage curricula review and development for business function areas.
  • Serve as SME for Learning Management System.
  • Maintain site training metrics for compliance and efficacy.
  • Lead training and continuous improvement projects.
  • Assess the effectiveness of technical training activities and processes.
  • Bachelor's degree or higher, preferred with 5+ years working in a GMP or regulated manufacturing environment.
  • May consider High School/GED with 15+ years working in a GMP regulated environment.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Strong understanding of adult learning theory and performance improvement principles.
  • Knowledge of principles and methods for curriculum and training design, teaching and instruction, and the measurement of training effectiveness required.
  • Ability to read, write & understand complicated product, equipment & OEM documentation & standard operating procedures with great attention to detail required.
  • Advanced skills with Microsoft Word, PowerPoint, & Excel; experience with instructional design software a plus.
  • Experience working in Learning Management System required.
  • Strong project management skills.
  • Leading pay and annual performance bonus for all positions.
  • Generous paid time off including 14 paid holidays.
  • Health Insurance, Dental Insurance, Vision Insurance - effective day one.
  • Guaranteed 8% 401K contribution plus individual company match option.
  • Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave.
  • Free access to Novo Nordisk-marketed pharmaceutical products.
  • Tuition Assistance.
  • Life & Disability Insurance.
  • Employee Referral Awards.
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