Specialist, Quality Assurance

Overview
The Quality Assurance Specialist role is responsible for supporting the International business development and sales team with onboarding clients and supporting customer lifecycle management with technical solutions, to ensure supply readiness, site compliance and streamlined international market entry with regulatory and business objectives being met. Primary focus will be providing support towards onboarding clients, quality assurance technical support towards PSF cultivated /processed product , receiving third party flower, alignment of Quality Agreements with all clients, Qualification/Validation of rooms/equipment and processes, product development and site QMS maintenance and development. Integral to their daily tasks, the Quality Assurance Specialist ensures strict adherence to established protocols and procedures, which may encompass batch record and label review, document control and conducting investigations, inspections, testing, and analysis, contributing to adherence to established standards and continual enhancement of quality processes.

Essential Responsibilities
Supply Readiness

• Support PSF cultivated/processed and third party bulk flower management through :

• Development of SOP's / records

• Qualification of vendors

• Risk assessment

• Audits
• Quality agreements

• Oversight of quality inspection and test data and communication with supplier on non conformances

• Label design , logistics and shipping support

• Facilitation and coordination of sampling and test results in relation to planning schedule and customer requirements to ensure on time delivery

• Tracking test data , monitoring deviations and OOS's

• Develop data management systems and analyse data to identify gaps and opportunities for system development

Customer Lifecycle Management

• Support qualifying and onboarding new customers to ensure quality and regulatory compliance
• Engage and communicate with a variety of international distribution partners to ensure alignment on quality agreements and changes for both planning and implementation of new contracts/business models' continuous improvements.
• Collaborate with site operations and QA/QC teams to manage risks and advocates for solutions in compliance with international regulatory expectations
• Maintenance of quality agreements with external customers (international and domestic wholesale).
• Liason with external customers in relation to quality- related requirements, questions, and concerns. Including supplier questionaires.
• Support product registration with export clients.
• Investigate non-conformances, conduct root cause analysis and follow up with corrective and preventive actions for departmental Deviations and CAPA to prevent future quality issues on products

• Development of QMS procedures.

• Facilitate and coordinate closure of deviations, CAPA's and complaints from international clients

• Facilitate and coordinate closure of deviations, CAPA's and complaints from wholesale clients - currently being done by Jenna

• KPI - data management and reporting

• Ensuring timely and accurate reporting via Quality Review Boards/Management Review on the performance of the QMS, along with associated required improvements

Technical Solutions Delivery

• Review and support GMP/GACP investigations associated with customer lot-related deviations, ensuring that appropriate follow-up actions (i.e., CAPA) are defined and implemented
• Integrate external requirements (regulatory, client-specific, market specific) with site processes through change control.

• Support Qualification/Validation - rooms and equipment

• Facilitation and coordination of the qualification and requalification of rooms/equipment and process/cleaning validation

• For existing rooms/equipment and processes - annually

• For new rooms / equipment and process for GMP expansion and/or reinspection support for Co-processors
• Facilitation and coordination requires on site support with departments for execution of the respective protocols and ensuring integrity of the data

Product Development support- Support coordination and execution of site trials, R+D studies through data gathering and analysis
- Perform administrative duties for document Control , facilitating documents, protocols and agreements for timely approvals through docusign
- Facilitate change control management through following up and facilitating implementation plans and effectiveness checks
- External audit management

• Facilitate and coordinate completion of action plans from observations in customer audits or audits done on customers for third party product
• Facilitate report writing and facilitation of audits

• Supporting GxP inspections and audits from both regulatory authorities and partners and supporting drafting of follow-up responses for all aspects of the business

• Risk management

• Facilitate and update risk assessments for the site and qualification and validations

• Facilitating/guiding risk management for GxP activities, including formulation of an appropriate risk question, managing external resources, and training and mentoring team members on QRM
• Coordinating risk management activities and overseeing the QRM system to enable timely identification and communication of quality and compliance risks, and appropriate mitigation and risk reduction actions
• Leading periodic reviews of QRM efforts to foster continual process improvement initiatives and assist in making improved, proactive decisions
• Perform internal audits on site QMS control systems and GMP processes
• Batch release for GMP bulk, finished product and GACP bulk allocated to international
• Review and verify daily records filled by operation staff, ensuring all corrections are made in a timely and organized manner
• Perform internal audits on processes and QMS and collaborate on corrective action completion with stakeholders to ensure product safety and quality
• If required support batch release on a daily basis through preparing quality documents, lab data review and label approval to fulfill order shipment
• Implement and maintain Deviation and Corrective Action Preventative Action (CAPA) modules to ensure compliance to site Quality Management System (QMS) and regulatory requirements
• Perform internal audits on processes and QMS and collaborate on corrective action completion with stakeholders to ensure product safety and quality
• Ensure that documentation, complaints, deviations, non-conformances, investigations, corrective and preventative actions, and change control are performed according to quality and regulatory requirements

Education
QUALIFICATIONS & EXPERIENCE

• Bachelor's Degree in Science or related discipline is required

Experience

• 3-5 years of QA experience in food production, pharmaceutical, cannabis and/or equivalent regulated industries

Knowledge & Skills

• Knowledge of applicable federal and provincial legislation, acts and regulations for Cannabis would be an asset
• Experience in developing SOPs, work instructions, and drafting technical reports
• Experience in handling customer complaints, change control, deviations, internal audits and CAPA.
• QA work experience in a GMP environment is an asset
• Strong analytical, and problem-solving skills with a focus on details, while working in a dynamic, fast-paced environment
• Customer focussed with emphasis on building strong customer relations and delivering custom centric solutions (internally and externally)
• Ability to lead by driving organizational and cultural changes needed to achieve strategic objectives; catalyzing new approaches to improve results by transforming organizational culture, systems, or products/services; helping others overcome resistance to change.
• Proficient in the use of Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Demonstrated good verbal and written communication skills in English
• Ability to manage priorities to meet changing business requirements and deadlines
• Exercising professional judgement and decision making
• Empathetic attitude with a passion to drive results.
• Must have the ability to maintain and pass an RCMP criminal record check and obtain security clearance. Please note our background check process includes proof of full COVID-19 vaccination status.
• Exemptions requested under Human Rights law will be addressed through Pure Sunfarms' accommodations processes
• Experience in developing SOPs and drafting technical reports
• Experience in handling customer complaints, change control, deviations, internal audits and CAPA
• Knowledge of applicable federal and provincial legislation, acts and regulations for Cannabis would be an asset
• Strong analytical, and problem-solving skills with a focus on details, while working in a dynamic, fast-paced environment
• Customer focused with emphasis on building strong customer relations and delivering custom centric solutions both internally and externally
• Proficient in the use of Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Attention to detail and excellent communication, both verbal and written skills
• Ability to manage priorities to meet changing business requirements and deadlines
• Empathetic attitude with a passion to drive results

Physical Requirements

• Work on site
• Ability to work at a desk in a seated position or standing if necessary