Corporate Quality System Specialist

The Role

The Corporate Quality System Specialist is responsible for leading the implementation and continuous improvement of GTI’s global Electronic Quality Management System (eQMS). The scope of this role includes quality systems monitoring and reporting, software license allocation, training, and troubleshooting. The Specialist will work closely with Corporate and Site Quality teams and cross-functional stakeholders to ensure the system operates effectively and efficiently for all users. 

Responsibilities

Key Accountabilities:

• Customize workflows to increase efficiency and reduce costs 
• Greater than 95% utilization of the eQMS system 
• Creation of training program for new and existing users 
• Achieve less than 48-hour resolution of troubleshooting tickets 

Essential functions:  

• Maintain the eQMS to ensure compliance with all applicable local, state, and federal regulations as well as industry best practices. 
• Work with IT and Data Management teams to identify opportunities for integration between the eQMS and other business software platforms as necessary to streamline data collection, reporting, and quality system processes. 
• Develop, maintain, and support additional modules/workflows to support the GTI’s quality system. 
• Manage ticketing system to resolve license requests and troubleshooting issues quickly. 
• Create training program for new and existing eQMS users. 
• Monthly review of license allocation and utilization. 
• Manage and adhere to annual budget for eQMS system, while continuously working to identify opportunities for cost savings. 
• Act as document controller.  
• Monitor document creation and revision to ensure users are complying with internal document control procedures, templates, and version control. 
• Approve document change requests (DCRs) and assign to document owners. 
• Facilitates periodic reviews. 
• Establish and maintain reports and dashboards from eQMS system.  
• Improve system notifications by reducing unnecessary or redundant messages.  
• Provide daily support to eQMS users. 

Safety & Compliance:  

• Be aware of hazards in the workspace. 
• Retain and understand department specific training. 
• Be compliant with area safety requirements, state regulations and PPE requirements while at GTI sites. 
• Follow GMP, biosecurity, sanitation or other quality and compliance requirements. 
• Perform record keeping accurately and completely as directed by a lead or supervisor. 
• Report and escalate safety & quality concerns. 

Working Conditions 

• While performing the duties of this job, the employee is regularly required to perform reaching, grasping, bending, stooping, talking, hearing, seeing and repetitive motions.  
• Ability to work in a fast-paced, changing, and challenging environment  
• Work involves occasional exposure to allergens (such as cannabis, tree nuts, and coconut oil).  
• Travel up to 10% may be required 
• • Travel includes visits to facilities in the field. 

Qualifications

• Bachelor’s Degree in a technical field preferred 
• 3+ years’ experience in a Quality Assurance function for a regulated industry 
• 1-2 years' experience managing or working within an eQMS system (i.e., C15, Veeva, Trackwise) 
• Demonstrated experience with software development or customization is preferred 
• Strong project management and communication skills 
• Exceptional attention to detail 
• High level of accountability and technical experience in a manufacturing environment 
• Comfortable working in a fast paced and challenging environment 
• Knowledge of the cGMP and quality management systems  
• Excellent verbal, written, and presentation skills 
• Exceptional computer skills in Microsoft® Office Suite (Access, Excel, Outlook, PowerPoint, Publisher, Word) 
• Understanding of the Cannabis laws, rules and regulations and passion to further their understanding and knowledge of the industry and the laws is desired 

Additional Requirements

• Must pass any and all required background checks
• Must be and remain compliant with all legal or company regulations for working in the industry
• Must possess valid driver’s license
• Must be a minimum of 21 years of age
• Must be approved by state badging agency to work in cannabis industry