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Position:     Training Mananger
Location:    Broomfield, CO

Description:
Primary responsibilities include planning, designing, implementing and evaluating the professional/technical training and development programs within the Broomfield site to support the site initiatives, manage the achievement of key business objectives, cGMP regulations and Good Business Practices in order to exceed all regulatory and Corporate requirements.  The position also coordinates with the site head and plant management in the development of these programs to ensure compliance with current regulations for employee training. The position is also responsible for site preparation to meet or exceed the training requirements set forth by the FDA and Good Manufacturing Practices during regulatory inspections.

Responsibilities:
  • Designs and develops training systems to meet the training and development needs of all site personnel.
  • Working with site management, assists in assessing skill and cGMP training needs and recommends appropriate action to satisfy those needs.
  • Monitors and evaluates the effectiveness of the implemented actions.
  • Confers with Managers and Supervisors to perform needs analysis to determine training direction.
  • Accountable for creating and implementing programs for the purpose of ensuring regulatory compliance, organizational effectiveness, business objective achievement and strategic plan performance.
  • Working with site management and employees, develops and implements a system for identifying on-going training needs of each position at the site.
  • Manages cGMP training documentation and procedures including the maintenance and administration of the Quality training system, timely data entry and training system audits.
  • Works closely with Learning & Development for the identification, planning and budgeting of non cGMP training initiatives and programs. Maintains the Site Training Room, equipment and supplies and a master training calendar.
  • Designs, implements and manages a Site Technical Services training program to include maintaining current training curriculum, training records and certifications and a Train-the-Trainer program.
  • Coordinates training efforts with Learning and Development and Continuous Improvement and other outside groups and vendors.
  • Designs, develops, implements and evaluates the job skills training, cGMP training, and management development as it relates to technical, regulatory and continuous improvement initiatives. Work with site leadership to identify individuals that can be department subject matter experts and attend train the trainer sessions.
  • Coordinates all Site training initiatives assuring that training courses are offered based upon the needs.
  • Perform training needs analysis and effectiveness assessments and deliver programs accordingly.
  • Coordinate/deliver other regulatory training as required.
  • Perform other related assignments and duties as required and assigned.

Minimum Requirements:
  • Ability to communicate thoughts and ideas either written or oral so that the recipient has a good understanding of the main points being communicated.
  • Adherence to all health, safety & environment requirements in support of departmental and site HS&E goals.
  • Work in a safe and efficient manner.
  • BS degree required.
  • BA/BS in Education, Business, Psychology, Communications, or related science required with MS Degree desired.
  • Minimum of 10 years experience in a training management role in cGMP pharmaceutical manufacturing operations/quality training environment with demonstrated knowledge of general training program development and delivery systems.



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