cGMP Training and QMS Specialist

Job Type:  100% onsite

Job Title cGMP Training and QMS Specialist, 

 The cGMP Training and QMS Specialist is responsible for developing, managing, and conducting the training program to ensure that all site employees are trained appropriately for their job role. This position is active in maintaining employee knowledge and compliance with cGMP requirements and company policies and SOPs. This role involves working with department management and SMEs to make sure training of employees is current and effective, including measuring trainee competence. With Manager oversight, this employee is responsible for the design and implementation of Quality driven projects.

• Develop and deploy a curriculum-based training system using organized modules 

• Is Subject Matter Expert for MasterControl training functions, including monitoring training, running training reports, reporting training metrics, managing job codes and curriculums within Master Control 

• Acts as a backup for the Document Control Supervisor 

• Supervise and provide guidance on the following activities: o Issue all training documents to employees and provide follow up to ensure training is completed on time. o Assign training modules to employees based on job functions. 

o Enter employee training information into the training database. 

o Administer continuous improvements to document management system

 • Other tasks as requested by management. 

• Perform other duties and responsibilities as delegated by Quality Management. 

• Performs other functions as required or assigned 

• Complies with all company policies and standards 

Education: Bachelor’s degree in life sciences, or other related field. 

• 6-8 years working in a GMP regulated industry is required.

• Previous experience working in a training capacity is desired.

• Previous experience with electronic document management systems is desired.