Quality Assurance Risk Manager Jobs in Massachusetts

 

The Role 

The Quality Assurance Manager is responsible for managing and enforcing all quality assurance and (QA) operations at GTI's production facilities. Specifically, the Quality Assurance Manager will play a key role in upgrading or developing and implementing GTI's quality assurance policies and standard operating procedures.This role will include the development and implementation of Product Quality programs, adherence to risk management programs, product quality tracking systems, ingredient management programs, allergen and sanitation management programs, and product safety practices. The individual will ensure that the team is following all GTI operating procedures and any quality regulations for federal, state, county, etc.  

Responsibilities 

• Oversee the facility's QA/QC department and ensure all employees understand and follow all standard operating procedures. 

• Edit, review, and approve standard operating procedures, batch production records, work instructions, and other site production documents. 

• Responsible for reviewing and releasing batches in accordance with state and GTI standard operating procedures and/or training others to do so. 

• Define, implement, and improve GTI's Quality Management System including document control, complaint handling, investigations, CAPAs, supplier management, sanitation, product quality checks, and positive release of batches. 

• Partner with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant quality system. 

• Implement and maintain sanitation and quality control practices that ensure the safety and quality of cannabis including purity and consistency. 

• Adhere to GTI's risk management, allergen, and sanitation management programs. 

• Review and approve decisions about whether to investigate a cannabis product complaint and review and approve the findings and follow-up action of any investigation performed. 

• Lead site Root Cause investigations and decisions about whether to investigate Product Quality issues (whether from customer complaints or onsite issues) and review, approve the findings and any CAPAs of the investigation performed. 

• Ensure adherence to GTI's program for designated positive product release and product safety. 

• Evaluate and investigate 3rd party lab results when necessary. 

• Lead Monthly Site Quality Review with site leadership as well as corporate quality leaders. 

• Review and approve planned deviations and changes to SOPs prior to implementation. 

• Manage non-conforming materials issues, including partnering with procurement regarding supplier issues and selection. 

• Execute state required trainings. 

• Track quality KPI's; analyze data, identify trends and execute corrective action plans. 

• Manage, train and develop QA/QC employees to perform in a proficient manner, providing motivation through personal example and interpersonal skills to create a cohesive unit. 

• Promote awareness and responsibility through training and regular communication throughout the facility. 

• Establish employee goals, monitor employee performance, and provide regular 1x1 performance feedback to help the employee succeed. Foster a high-performance culture through active leadership and create a strong sense of accountability within the department. 

Working Conditions 

• Work involves daily exposure to allergens (such as cannabis, tree nuts, and coconut oil). 

Qualifications  

• Demonstrated experience with all QMS elements as defined in responsibilities above. 

• Minimum 5 years of QA/QC experience in a regulated production organization. FDA cGMP competency in 21 CFR Part 111 & 117 preferred. Cannabis experience is a plus. 

• Bachelor's degree in food science, Chemistry, Engineering or similar preferred

• 3-5 years of progressive leadership responsibility with a proven track record of building and developing QA/QC processes and systems preferred. 

• Strong ability to effectively present information and respond to questions from senior management, function heads, managers, supervisors, and all levels of employees. 

• Highly collaborative influencer who is an effective communicator and relation builder/networker 

• SQF, ISO, GMP, ASQ, HACCP or similar certification experience preferred 

• Experience using an eQMS (electronic quality management system) preferred. 

• Ability to deliver specific organizational goals and effectively develop, grow and manage a team to achieve objectives. 

• Track record of engaging teams and creating a collaborative QA/QC culture 

• Experience leading root cause problem solving 

• Unassailable integrity and ethics 

• Solid understanding of the Medical Marijuana laws, rules and regulations is preferred, with a passion to further their understanding and knowledge of the industry and the laws. 

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