Quality Assurance / Quality Control Associate
The Quality Assurance/ Quality Control Associate is responsible for learning, teaching, implementing, and enforcing SOP compliance in all departments. The QA/QC Associate ensures and monitors adherence to all facility SOPs relating to current Health Canada regulations, GMPs, and other applicable regulations. As the QA/QC Associate you would be responsible for record maintenance of all transactions involving restricted drugs, including receiving and shipping, and inventory; as well as, ensuring that quality standards are met and that the storage and distributions specifications of each product are met. The QA/QC Associate performs quality assurance functions for products prior to distribution. They report to the Head of Quality Assurance/ Quality Control.
- Assists the Head of Quality Assurance/ Quality Control in managing the Quality Management System.
- Ensure efficiency of a Quality Management System for all cultivation, harvest, processing and packaging activities. Monitor process control points and take measures to eliminate deviations.
- Writes, reviews, and updates SOPs and policies to ensure continuous compliance.
- Ensures and monitors adherence to all facility SOPs relating to current GMPs and other applicable regulations; including but not limited to, Change Controls, Deviations, Recalls, Returns and Customer Complaints.
- Ensures and enforces Good Documentation Practices on all applicable documents relating to GMPs.
- Responsible for training of site management and employees on applicable SOPs and GMP related topics. Responsibilities include the planning, execution and maintenance of employee training records as well as testing to ensure training effectiveness.
- Participate in internal and external audits for Health Canada, GMP and QA. This includes addressing issues, preparing response reports and regulatory submissions.
- Monitor supplier performance. Work with operations and cultivation to resolve quality issues with production inputs.
- Ensure integrity of live and dried plant population, as well as, oil products at Valens, including oversight of annual and semi-annual inventories. Investigate variances and reconciliations.
- Oversee sampling of raw materials and finished goods for testing and retention purposes, when applicable.
- Responsible for the release or rejection of finished products.
- Support Site Security Officer in managing narcotic cage/vault security and access.
- Assist in the investigation and report all suspicious narcotic transactions and losses.
- Assist with the authorization, processing and managing all returned narcotic product.
- Assist with operational narcotic activities as required.
- Review COAs and all other private brand documents.
- Maintain SDS.
- Act, at need, as QAP in the narcotic sector.
- Complete all other tasks related to the position, as assigned by the Head of QA/QC.
- Bachelor of Science Degree (BSc) in Chemistry, Bio-Chemistry, Pharmacology, Pharmacy, Microbiology, Chemical Engineering, Medicine, Dentistry or Veterinary Medicine.
- Meet Health Canada requirements for AQPIC.
- Able to successfully obtain clear 10-year history police record check.
- 2-5 years of work experience
- Knowledge of GMP, ISO 9001, and Health Canada regulations
- Previous AQPIC or QA experience
- Previous Health Canada Security clearance and work experience with a Canadian Licensed Dealer or Licenced Producer is an asset
- Knowledge of GLP principles, ISO 17025, and laboratory experience an asset
- Knowledge and experience in chemistry, pharmacology and plant biology an asset
- Strong knowledge of MS Word, Excel and Outlook
- Excellent analytical skills and above average attention to detail
- Excellent time management and prioritization skills
- Oriented towards quality work and service
- Capable of multitasking with minimal supervision
- Excellent English communication skills both written and verbal