Quality Assurance Lead
2 weeks ago
The Quality Assurance Person (QAP) is accountable for the development, implementation and ongoing monitoring of the quality assurance and control systems in compliance with the Cannabis Act. The Quality Assurance Person (QAP) must have strong leadership qualities and the ability to liaise with internal and external departments.
Key Responsibilities
- Ensure all production, packaging and labelling activities are conducted according to applicable legislation including but not limited to GPP, GMP and cannabis regulations
- Review and approve Standard Operating Procedures (SOPs), Work Instructions, Forms and Master Batch Record (MBR) documentation
- Ensure all production, packaging and labelling activities are carried out according to approved Standard Operating Procedures (SOP)
- Assist with preparing reports required by the cannabis regulations
- Review and approve labels for final cannabis products for accuracy and compliance with cannabis regulations
- Ensure all record keeping for methods and procedures are updated and current as per the Cannabis Regulations
- Manage preparation and handling of mock/actual recall events.
- Conduct and report quality complaint investigations, including adverse reactions
- Evaluate the impact of change requests on product quality, quality management systems and regulatory compliance
- Provide support for on-site audits/inspections conducted by external authorities Initiate corrective and preventive actions (CAPAs) and conduct investigations to address non-conformances, out-of-specification results, and ongoing/trending deviations, as needed
- Oversee implementation of methods and procedures for inspecting, testing and evaluating the quality of cannabis and cannabis products
- Assist with the Document Management System, document control, and SOP training
- Support generation and management of Quality Agreements
- Ensure only pest control products registered for use on cannabis under Pest Control Products Act (PCPA) are released for production use
- Approve and release starting materials; packaging materials; intermediate, bulk and finished products Assist with inventory management
- Establish and maintain good working relationships with vendors and third-party service providers.
- Participate in improvement initiatives and special projects, as required
- Manage, lead and motivate a team of individuals
- Schedule team members and department activities appropriately Delegate departmental tasks accordingly
- Support in the delivery of a meaningful performance management program
Qualifications and Skills
Academic/Educational Requirements
- Minimum of Bachelor’s degree in related scientific field with regulatory discipline required or shows demonstrated experience in the required role.
- 2 - 5 years of education and/or experience in scientific field preferred.
Required Skills/Experience/Knowledge
- QA experience in a GMP/GPP quality position in pharmaceutical or cannabis industry or equivalent is considered an asset
- Health Canada Security Cleared
- 1-2 years of experience in preparing and writing standard operating procedures, test methods, sampling protocols or other quality management system documentation is considered an asset.
- Strong scientific, analytical and mathematical skills.
- Able to understand and interpret laboratory test results, validation studies, stability protocols, and safety and efficacy studies.
- Excellent verbal and written communication skills; and ability to clearly communicate requirements and provide direction to others in a manner that can be easily understood.
- Excellent organization skills and the ability to adapt to changing priorities and deadlines.
- Analytical thinker with excellent root-cause analysis and problem-solving skills.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Knowledge of cultivation, plant chemistry, and chromatographic techniques is considered an asset Regulatory Auditing
- Able to work independently and efficiently with little supervision
- Health Canada Security Clearance and work experience with a Canadian Licensed Producer (LP) is considered as an asset
**Job Types**: Full-time, Permanent
**Salary**: $70,000.00-$95,000.00 per year
Flexible Language Requirement:
- French not required
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Weekends as needed
Ability to commute/relocate:
- Edmonton, AB: reliably commute or plan to relocate before starting work (required)
**Experience**:
- quality assurance: 2 years (required)
Work Location: In person
Application deadline: 2023-11-25
Expected start date: 2023-11-25
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