Quality Specialist

POSITION SUMMARY:  

The Quality Specialist will be responsible for supporting the national standardization of processing and manufacturing procedures, technology, and business practices at a State level.  This role will support ongoing operations, working closely with Quality leadership to continuously improve operations.  The Sr. Quality Associate will also be responsible for training site team members on SOPs using the Quality Management System.  This role will develop key relationships with other Curaleaf teams including, but not limited to: Compliance, Operations, and Cultivation.      

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Implement, monitor, and maintain all Quality programs and processes within the state. 

• Assist in the development and implementation of state-specific Standard Operation Procedures (SOPs) and work instructions. Continuously monitor SOP implementation and operational adherence to written procedures. 

• Identify all potential, serious, or chronic problems affecting product quality or compliance. 

• Participate in updating Quality procedures and validation processes. Review and assist with policy changes and updates applicable to the state. 

• Establish and enforce quality assurance standards and provide technical recommendations in production and packaging. 

• Initiate RCA and CAPA for state events and work with compliance and operational teams to correct and document Non-Conformance. 

• Develop, implement, and monitor sustainment of corrective actions resulting from quality event investigations and internal and external audits. 

• Assist, encourage, and participate in continuous quality improvement process through reinforcement of product quality, new processing and manufacturing technologies, creation of specifications, and performance and oversight of various auditing and investigation actions. 

• Perform audits against cGMP standards and ensure integrity and sustainment of the quality systems. 

• Partner with state compliance and operational leadership to ensure the company is maintaining all standards set forth by State and Federal regulations and guidelines 

• Monitor preventative maintenance and calibrations for site instrumentation. 

• Enforce and monitor the vendor approval process for incoming products and consumables, perform risk evaluations, and as needed conduct supplier audits. 

• Audit all processing operations. Identify risks and mitigate potential impact to employee safety, product quality, and cGMP compliance. 

• Enforce and monitor the hold and release program for the state. 

• Work closely with operations to develop, revise, and maintain national SOPs at the site level to allow for reasonable specialization and adaptation based on state regulations. 

• Integrate State-specific SOPs into the electronic Quality Management System (eQMS) 

• Assist site leadership with training and qualification procedures for team members. 

• Responsible for communicating all document changes to Document Control Manager to update the centralized document library and ensure document retention in compliance with the requirements of 21 CFR part 11. 

• Perform periodic review of procedures, forms, logs and master batch records (MBRs). 

• Direct and implement changes into procedures identified by Change Control and CAPA processes. 

• Track new document creation, administrate document’s controlled copies, administrate and archive inactive documents, maintain an active document history file, and ensure user access to controlled document’s original copy in collaboration with Document Control Manager. 

• Manage the roll-out and adoption of the eQMS at a state level. 

• Maintain applicable modules and coordinate routine uploads of required documents into the eQMS. 

• Participate in finished goods testing up to and including working hands on with testing labs on site gathering samples and verifying testing. 

• Enforce safety and security procedures in compliance with OSHA and local EHS regulations; report potentially unsafe conditions; monitor for proper use of equipment and materials. 

• Provide routine status updates and relevant information and priorities to the Quality team. 

• Promote a culture of quality and change management by empowering team members and colleagues. 

• Additional duties and responsibilities will be assigned as necessary. 

• Perform other duties as assigned. 

QUALIFICATIONS: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.  

Minimum Qualifications: 

• 5+ years of relevant work experience. 

• Advanced MS Office and Excel skills required 

• Excellent oral communication skills with attention to detail. 

• Results-driven and task-oriented. 

• Flexible and creative, while maintaining a strong work ethic and the ability to meet critical deadlines. 

• Ability to prioritize under pressure and identify and help resolve roadblocks facing the Operational Teams and processing and manufacturing projects in particular. 

• Excellent communication skills and ability to interact professionally at all levels of the organization, with vendors and outside stakeholders. 

Preferred Qualifications: 

• Undergraduate Degree Preferred.  Degree in life sciences, or similar discipline preferred. 

• QMS experience preferred.     

• Strong knowledge of cGMP preferred.