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Curaleaf · 1 day ago

Quality Specialist

Ravena, NY

Full-time

Onsite

Mid, Senior Level

$63K/yr - $77K/yr

5+ years exp

Curaleaf is a leading global cannabis provider committed to quality and innovation. The Quality Specialist will support the standardization of processing and manufacturing procedures at the state level while working closely with Quality leadership to improve operations and ensure compliance with state and federal regulations.

Alternative MedicineCannabisHealth CareMedical

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

Qualification

QMS experienceCGMP knowledgeAdvanced MS OfficeOral communicationFlexibleCreativePrioritizeProfessional interactionTeam empowermentAttention to detailResults-driven

Required

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