JOB REQUIREMENTS: 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. *****
OTHER EXPERIENCE AND QUALIFICATIONS: 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.
***** APPLICATION INSTRUCTIONS: Apply Online:
https://recruiting.paylocity.com/recruiting/jobs/Apply/2460724/SHINE-Technologies-LLC/Training-Specialist---Therapeutics?source=Job%20Center%20of%20WISC