Will ensure quality and compliance of a WIP storage / Secondary packaged goods facility related to the Cannabis Industry. Reporting to the General Manager, the Quality Assurance (QA) Specialist will ensure all quality standards and current procedures are in compliance to the governed regulatory body of the facility.
MAJOR DUTIES AND RESPONSIBILITIES:
- Write, maintain and audit Standard Operating Procedures, Client Specifications, work instructions and any other documentation as required.
- Enforce GMP requirements and regulations per operating procedures
- Ensure that all warehousing, manufacturing, packaging, testing storage and distribution activities are performed in conformance to Customer Specific, Health Canada, FDA, AIB and company policies and/or standard operating procedures.
- Interact with Operations and Customer Service to work as a team to coordinate movement of product, components and finished goods between departments and customers
- Work closely with all departments to ensure staff are working in compliance with internal policies and procedures, external client expectations and GMP.
- Work closely with Supervisors and Client to ensure production schedules meet required completion dates.
- Ensure and perform audit checks to production lines and utilize QA release processes to ensure conformance to standards
- Provide recommendations for process improvement to reduce cost and improve quality.
- Host regulatory and client audits and assumes responsibility for ensuring that stakeholders are included in proposals for corrective actions.
- Assist in creating and maintaining an environment that promotes positive communication within the facility as well as fostering teamwork within the operation.
- Maintain the integrity and performance of quality expectations with Lean cost effective strategies that meet business objectives
- Manage overall quality assurance systems and processes to ensure the highest level of product quality on a consistent and reproducible basis
- Contribute to change management process as project needs arise
- Oversee quality investigations for root cause and CAPA determination.
- Control and distribution of all the companies quality documentation
- Enforce GMP requirements
- Fulfill the duties of a QA Specialist under the Occupational Health and Safety Act including; safety, violence and harassment laws.
- Ensure product hold, traceability and batch / lot control are strictly maintained
- Responsible for audits internal and external
- Degree in Food Science or related discipline from University or College.
- A post-secondary degree in science or engineering
- At least 5 years Quality Assurance experience
- 5 years’ experience working in quality assurance, methodologies and policies
- Strong leadership
- Previous audit experience and/or lead auditor training (Health Canada and/or FDA experience)
- Working knowledge of applicable GMP regulations
- Knowledge of ACMPR regulations for Health Canada is preferred
- Proven track record in driving continuous improvement in a manufacturing environment
- Driven to provide excellent Customer Service with effective customer interaction skills and flexible working hours.
- Experience in developing and monitoring of project QA/QC budgets
- Ability to develop and maintain relationships with internal and external business partners.
- Proven communication skills both verbal and written.
- Comfortable with being directly involved in a fast paced production environment.
- Capable of working with minimal supervision.
- Must be flexible and willing to work additional hours when required.
- Previous experience with warehouse systems such as Red Prairie, pack manager or SAP a definite asset.
- Must have a good understanding of quality standards and GMP in a production environment.
- Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor.
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