Junior Quality Assurance Person - Jobs in Strathmore, AB

Job Description

Summary: The Junior Quality Assurance Person will be responsible for assisting in the coordination of work to ensure the successful implementation of Cannabis Act, Cannabis Regulations, Good Manufacturing Practices (GMP) and Good Production Practices (GPP) production standards in pursuance of regulatory compliance and achievement of business goals. The QAP will work hand in hand with production, maintenance, facilities and shipping teams to ensure that quality standards are recognized, implemented, enhanced and maintained throughout all of production operations.Key Responsibilities:

• Provides oversight on the performance of all Quality Assurance (QA) personnel, practices, and procedures
• Serves as the Health Canada Compliance Manager and one of the primary contracts for Health Canada
• Initiates the development and ongoing amendment of the organization’s Standard Operating Procedures (SOPS)
• Serves as the internal compliance auditor ensuring the organization’s compliance with all regulatory rules and regulations
• Ensures that the QA practices at each of the organization’s facilities align with the company’s business plan and GMP/GPP standards
• Develops and executes product quality and yield improvement strategies
• Assures regulatory requirements are embodied in all of the organization’s policies, directives, practices, processes and forms
• Establishes and maintains product quality documentation by writing and updating quality assurance procedures
• Establishes the following quality and reliability standards by studying their respective requirements, processes, and procedures:
• Raw material standards

o In-process product inspection standardso Standards for the disposition of finished productso Rework standards

• Maintains and improves product quality by enforcing QA policies and procedures and government requirements; completing product, company, system, and compliance audits; investigating customer complaints; and collaborating with members of senior management to develop new product and engineering designs as well as manufacturing and training methods
• Develops QA plans by conducting hazard analyses; identifying critical control points and preventative measures; establishing critical limits, monitoring procedures, corrective actions and verification procedures
• Prepares product and process quality reports by collecting, analyzing and summarizing information and trends
• Assists in regulatory submission activities from the development/investigational stage through to filing, approval, and post market submissions
• Develops regulatory strategies for current and future programs in collaboration with other senior management
• Provides expertise and support to regulatory inspections including quality representation on all activities
• Develops, updates, and maintains quality systems and manuals that comply with the Cannabis Regulations, Cannabis Act, and GMP/GPP standards
• Investigates product non-conformances; reviews material, document findings and responses for complaints. Manages product holds, reprocessing actions, and final disposition processes for non-compliant resources
• Enforces regulatory requirements in addition to reading and being familiar with the organization’s security directives
• Directs activities of the Quality Assurance department which support the company’s quality vision
• Maintains QA staff by working the Human Resources Manager to recruit, select, orientate, and train of the department employees
• Participates in developing quality metrics and goals, leading efforts in rolling them out to the organization’s facilities
• Provides guidance on production processes where applicable, including troubleshooting, GMP/GPP compliance, and control of contaminants
• Communicates with Operations and Production Technology Manager and relevant facility staff including Master Growers and Quality Assurance personnel
• Ensure investigation and annual product review are conducted in a compliant matter

Qualifications:

• BSc/MSc in Chemistry/Biochemistry/Biology/Food or similar discipline. MSc is preferred.
• 3-5 years of experience in a QA/Regulatory manufacturing environment.
• Existing CTLS security clearance for QAP.
• Experience in managing Quality Management Systems and creating Preventative Control Plans
• Strong understanding of Health Canada, and GMP/GPP requirements for pharmaceutical, health, food processing, and cannabis products.

Job Type: Full-timeSchedule:

• 8 hour shift

Work remotely:

• No