Quality Auditor - AQAP
Leamington, ON
About Auxly Cannabis Group Inc.
Auxly is a leading Canadian cannabis company dedicated to bringing innovative, effective, and high-quality cannabis products to the wellness and adult-use markets. Auxly's experienced team of industry first-movers and enterprising visionaries have secured a diversified supply of raw cannabis, strong clinical, scientific and operating capabilities and leading research and development infrastructure in order to create trusted products and brands in an expanding global market. Learn more at www.auxly.com and stay up to date at Twitter: @AuxlyGroup; Instagram: @auxlygroup; Facebook: @auxlygroup; LinkedIn: company/auxlygroup/.
What can you expect to do:
- Complete activities and responsibilities of the Alternate Quality Assurance Person as defined in the Cannabis Act and associated Cannabis Regulations.
- Participate in internal and external audits such as Health Canada Inspections. Review respond and monitor Health Canada observations and internal corrections.
- Responsible for participating in the approval, auditing, and archiving of documentation associated with the manufacturing, testing, sampling, packaging, and labelling of all cannabis products to ensure regulatory compliance.
- Ensure that master documents are controlled and secured in accordance with Quality and GPP requirements.
- Ensure compliance with standards, methods, and procedures for inspecting, testing and evaluating company products.
- Participate in investigations into product non-conformances and document findings in non-conformance reports. Support product holds, reprocessing actions, and final disposition processes for noncompliant materials/products.
- Participate in Quality events (complaints, incidents, deviations, CAPAs, etc…) as required and ensure appropriate corrective and preventative adjustments are implements, as needed.
- Audit quality assurance documentation as assigned to identify errors, request corrections, and relevant deviations.
- Review revised documents when returned with corrections completed to confirm proper completion.
- Report results of audited documentation to the Quality Assurance Person to support the release of product or otherwise release product having met all specifications.
- Audit finished products batch records, and laboratory testing records and perform product release prior to sale for products having met all specifications.
- Provide feedback to the QA Associates and QC Technicians on areas of batch records that have consistent errors, so they can provide retraining or support employees and/or appropriate change controls.
- Participate in the self-inspection program. Provide support during regulatory and customer audits.
- Monitor trends to determine where focus efforts are needed for documentation improvement.
- Prepare metric reports for each department as requested. Support other areas of the department for record retention.
- Complete all duties and tasks in compliance with company Standard Operating Procedures.
- Maintain the highest level of quality and safety standards in all actions, duties, and behaviours.
- Other duties, responsibilities and activities as required.
What we are looking for
- Post-Secondary education with a background in a scientific, engineering, or a related technical discipline.
- Minimum of 3 years experience in a regulated manufacturing environment within a Quality department.
- Significant experience in implementing and/or maintaining procedures.
- Significant experience in monitoring compliance for a facility, its equipment, sanitation, and process controls.
- Significant experience with manufacturing investigations, root cause analysis, the implementation of corrective & preventative actions, and subsequent effectiveness checks.
- Experience with consumer complaint-derived investigations and associated actions.
- Significant experience in developing and monitoring compliant product specifications and associated process controls through the manufacturing process to support the release of finished goods for consumer consumption.
- Understanding of analytical test methods and methods validations.
- Understanding of recall procedures and recall communication requirements.
- Understanding of qualifications and continuous validations.
- Strong communication, both oral and written.
What can set you apart
- Strong technical writing skills and mathematical skills.
- Problem solving with a solution driven psychology.
- Active personable and constructive engagement with all staff.
- Software knowledge and/or adaptive learning within Veeva, Sage, and Excel.
How we hire
Auxly Cannabis Group Inc. is an equal opportunity employer and encourages applications from all qualified individuals. We thank all applicants for their interest, however, only those selected for an interview will be contacted.
We provide accommodation for job applicants with disabilities during the recruitment process in accordance with applicable laws. Please contact us to request accommodation.
