Training Specialist - Therapeutics

Description

SHINE Technologies is immediately seeking a Training Specialist. This is a new position within SHINE Technologies, (SHINE Therapeutics). SHINE is a fast paced, fast growing radiopharmaceutical company and expects significant growth. The Training Specialist will implement a training program that ensures GMP employees are initially trained and kept up to date on their training requirements. cGMP training is a continuous process due to the constant updating of procedures and implementation of new processes and technologies.  

Duties and Responsibilities:

Specific duties and responsibilities include, but are not limited to:

• Work with all department heads to develop and maintain a curriculum-based training program that includes all functional areas. Training program will include but not limited to read-understand, lecture, scenario based on the job training, and quizzes to demonstrate understanding of the tasks.
• Prepare training materials and training aids.
• Organize and Develop Classroom and Self training to include but not limited to:
• Develop and maintain training courses to meet the organizational requirements
• Work with various departments to ensure employees are placed in the appropriate classes
• Develop and conduct special training requirements and/or requests as defined by departments
• Work with each department to develop a method to test and certify that employees understand and are capable of completing assigned tasks.
• Maintain the training program for cGMP activities in the ACE LMS system. Develop a training matrix within the ACE system. 
• Work cross-functionally with Operations, Quality Control, Supply Chain, Facilities, Engineering, Regulatory and Quality Assurance to identify cross-functional training required.
• Using the ACE dashboard, develop a training notification process to all employees to keep them up to date on their training requirements.
• Assign training as needed as procedures are updated/revised.
• Ensure on-time completion of training activities. 
• Develop and maintain a new employee onboarding training program.
• Develop and Conduct annual cGMP training as required by the regulations.
• Conduct any special cGMP training as required by the business unit.

Requirements

• BS in scientific discipline.
• Operations, Analytical and Microbiological knowledge is preferred.
• Previous experience working in a GMP environment (4-6 years) with general knowledge of cGMP, ICH, and other global compendia. 
• Willingness to be “hands on” and understand new technology required.
• Ability to write training procedures.
• Ability to interpret technical SOPs and develop training programs/sessions.
• Proficiency in Microsoft Office platforms
• Previous work related to radiation pharmaceuticals preferred.

Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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