Quality Specialist

Quality Specialist

Job Type: Full Time; Exempt

Schedule: Monday to Friday - 7:00 am to 4:00 pm

Compensation: $62,000 to $70,000 based on qualifications and experience - 7.5% quarterly bonus incentive

Who You Are:

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 Quality Specialist 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.     

What You Will Do:

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

What You Will Bring:

• Undergraduate Degree Preferred.  Degree in life sciences, or similar discipline preferred.
• 5+ years of relevant work experience in a quality management or manufacturing setting
• Advanced MS Office and Excel skills required and QMS experience preferred.    
• Excellent oral and written communication skills with attention to detail.
• Strong knowledge of cGMP preferred.
• 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.

Physical Requirements

• Ability to sit or stand for long periods of time throughout scheduled shift
• Ability to lift up to 30 pounds unassisted
• Ability to have close vision and read small print up to 20 inches away
• Ability to use and look at computer screen for long periods of time