Quality Assurance Manager/qap

3 weeks ago

Calgary, Canada Distex Bioventures Full time

**Role Summary**

The Quality Assurance Manager is responsible for the verification and validation of quality assurance within the facility. They are responsible for ensuring that cannabis products produced meet the organization’s objectives for quality, safety, regulatory, and customer expectations in accordance with the Cannabis Act, Cannabis Regulations, ICANN GAP, and any additional relevant regulations. The QA Manager will advise on, establish, and monitor Quality Management Systems, and coordinate activities to meet production process and product quality standards.

**Roles and Responsibilities**
- Manage the licensed site’s Quality Assurance Department, QA Associates, Technicians etc. and provide oversight and leadership to the department.
- Oversees both quality control (QC) and quality assurance (QA) pertaining to business, production, facility, security, storage, packaging, labeling, and Good Production Practices (GPP) for the Cannabis Regulations as well as ICANN GAP Standards.
- Responsible for ensuring GPP and ICANN GAP compliance and management of the Quality System, including but not limited to change controls, deviations, incidents, recalls, returns, and customer complaints.
- Communicate and summarize compliance performance and results (e.g. highlight self-inspection issues, out-of-specification and/or out-of-trend results, etc.).
- Ensure compliance with regulations through auditing and quality systems.
- Support the self-inspection program and recommend follow-up actions with an emphasis on areas identified as non-compliant.
- Supports continuous quality improvement of finished products through reinforcement of product quality and safety programs, sanitation programs, and oversight of the security system.
- Ability to actively develop, update, approve, implement, and maintain Standard Operating Procedures (SOP).
- Oversee critical/technical review of Certificates of Analysis (CofAs), test results, procedures, and production equipment, including equipment qualification and validation and vendor qualification.
- Investigate product non-conformances; conduct material reviews for complaints, and document findings and responses. Manage product holds, reprocessing actions, and final disposition processes for non-compliant resources.
- Investigate all client complaints and adverse reactions.
- Review all Certificates of Analysis from the contact laboratory and release/reject batches and lots accordingly. Document all conclusions and follow-up actions.
- Responsible for training of site management, warehouse employees, and customer service on SOPs and GPP and ICANN GAP-related topics, and includes the planning, execution, and maintenance of employee training records as well as testing to ensure training effectiveness.
- Maintain a valid security clearance.
- Lead in developing, reviewing, and maintaining SOPs & Quality Management Programs and projects to ensure GPP compliance under the Cannabis Act/Regulations.
- Work cross-departmentally to implement SOPs (i.e. Operations, Regulatory, Security).
- Oversee and develop a pest control program and ensure pest control procedures are authorized under the Pest Control Products Act or the Cannabis Act.
- Create quality control programs/systems for cannabis storage.
- Develop programs around Record-Keeping Methods for sanitation of premises, equipment, cleanliness, hygienic behaviour of personnel, and facility maintenance.
- Establish and maintain record-keeping systems and ensure employee adherence to proper documentation practices.
- Conduct testing on each lot or batch of cannabis prior to release for sale; ensure testing is conducted using validated methods, investigating deviations and out-of-spec results.
- Collaborate to develop and perform internal audits regularly to determine quality assurance compliance according to Cannabis Regulations.
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Function as QAP in matters relating to GPP, ICANN GAP and Record-Keeping compliance during Inspections.
- Review and approve methods and procedures pertaining to GPP and ICANN GAP within the licensed site.
- Ensure cannabis quality meets standards prior to release for sale.
- Additional duties as assigned.

**Requirements**:

- Minimum Science Diploma or Bachelor of Science (B.Sc.) in a technical discipline (food, chemical, or biological sciences preferred). MSc preferred.
- Previous experience in Quality Control and Quality Assurance in a GMP and HACCP-regulated environment, such as cannabis, food or pharma.
- Experience establishing and maintaining version-controlled standards, policies, procedures, and workflows. General understanding of other operations/functional areas.
- Proficient understanding of cannabis products and related test methodology.
- Willing to relocate if required.
- Strong understanding of the Cannabis Regulations is required.

**E

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