Manager of Quality Assurance, Recall, and Regulatory Affairs

6 days ago

Thunder Bay, Canada Sophia's Garden (Artisan) Inc. Full time

Job Title: Manager of Quality Assurance, Recall, and Regulatory Affairs (“QAP”)

**Background**:
Sophia’s Garden (Artisan) Inc. (SGA) has a Standard Processing license available under The Cannabis Laws. SGA is a CPG company in the business of infusing foods (a range of products ultimately) with either cannabis or hemp extracts (THC and CBD and related isolates) as a large-scale, low-cost manufacturer. The regulations provide requirements for quality-controlled, cannabis-related products, produced under secure and sanitary conditions, to Canadian markets. The future may also require GMP level standards for export markets as SGA management deems “export” to be an expansion of our business opportunities.

As a Senior Manager as well as the Leader of the QA team, the Manager of Quality Assurance, Recall, and Regulatory Affairs (“QAP”) is responsible for ensuring the Cannabis Laws are met through programs, practices, and protocols, which are executed effectively at the facility, with full responsibility for the Health Canada program including updates, inspections, mock recalls, and thorough documentation of all related records. By leading in a values-aligned fashion, the QAP plays a critical role in creating and maintaining a service-oriented team built on the foundations of Product Safety.

SGA is currently expanding our operations to increase capacity, to meet existing and future market conditions. Therefore, the QAP will also lead research into cannabinoid and food safety, improvement, and development of new products based on the science and results drawn from the research as well as community feedback, such a focus groups. The QAP will be central to the addition, expansion, and development of production lines.

**ROLES AND RESPONSIBILITIES**:

- The QAP will ensure that the physical, chemical, and microbiological specifications of all raw materials, intermediates and finished goods comply with all regulatory and corporate quality specifications.
- The QAP will ensure the timely rejection, isolation, and disposition of all non-compliant materials and will arrange/provide analytical services as required.
- The QAP will provide technical support to the manufacturing operation by developing/maintaining the Edibles Preventative Control Plan (PCP), identifying, and assisting in the resolution of processing problems, coordinating equipment validation, expediting and facilitating corrective actions.
- The QAP ensures processing lines and facilities are following relevant food safety (PCP) and GPP programs through sanitation and preoperational inspections and assisting with GPP self-inspections and internal audits when required.
- Supervise a staff of QA Technicians and/or QA Coordinators ensuring that tasks are conducted consistently, efficiently and aligned with the needs of the business.
- Plan QA staffing requirements according to production demands.
- Build and maintain a HACCP program.
- Responsible for SOP/GPP/PCP document and training: maintenance, monitoring, and verification.
- Identify any ISO 17025 or SOP Work Requests generating from Interior Premises Audits, Sanitation Monitoring, Pre-op inspections, 3rd Party audits, or any Health Safety failures.
- Assist and accompany Health Canada inspectors during performance of their reviews or inspections and sampling as required.
- Assemble and lead annual MMPR/ISO reassessment team and conduct pre-requisite program reassessment and audit.
- Lead safety failure recall programs ensuring SOP compliance.
- Prepare and support various Audits including license recertification, internal audits, etc.
- Perform record verification as well as QA personnel competence verification.
- Responsible for the preparation of production-related batch records including THC volumes and/or masses for monthly regulatory reporting, and as required.
- Assist with analysis of data to determine root cause of deficiencies and provide feedback on performance and necessary improvements.
- Participate in cross functional SOP development and ensure that facility SOPs and related documents are controlled, in a correct format, properly stored, and distributed as per manufacturing excellence requirements, including license or regulatory reassessments, program changes, etc. as necessary.
- Lead cross functional teams completing incident investigations where product safety or product quality may be compromised.
- Advancing an attitude of continuous improvement and training of employees at hourly and salary levels.
- Take lead on execution of various initiatives to improve the quality and safety of our products.
- Support and/or lead change management activities related to processes, programs and/or systems.
- Support QA team as required (back-up for various roles, etc.).
- Other duties as required by SGA senior management.

**OTHER CONSIDERATIONS**:
1. Food Engineering: a bachelor’s degree in food engineering as well as experience in designing new production lines, dimensioning required equipment,

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