Quality Assurance Person
Entourage Health Corp. (previously known as WeedMD Inc.) is the publicly traded parent company of WeedMD RX Inc. a licence holder producing and distributing cannabis products for both the medical and adult-use markets. The Company owns and operates a 158-acre state-of-the-art greenhouse, outdoor and processing facility located in Strathroy, ON as well as a fully-licensed 26,000 sq. ft. Aylmer, ON processing facility, specializing in cannabis extraction. With the addition of Starseed Medicinal, a medical-centric brand, Entourage has expanded its multi-channeled distribution strategy. Starseed’s industry-first, exclusive partnership with LiUNA, the largest construction union in Canada, along with employers and union groups complements Entourage’s direct sales to medical patients. The Company maintains strategic relationships in the seniors’ market and supply agreements with Shoppers Drug Mart as well as eight provincial distribution agencies where adult-use brands Color Cannabis and Saturday are sold.
The Quality Assurance Manager is responsible to ensure that products produced by the Company meet the expectations and requirements of Company's SOPs and Specifications, and applicable provisions of the Good Production Practices (GPP) under the Cannabis Regulations, as appropriate to a Federal Licence Holder, and, if necessary, with other regulations and regulatory requirements as the case may be. The Quality Assurance Manager oversee, coordinate and provide necessary guidance to the Quality Assurance Units of the Site of the company.
Key Roles & Responsibilities:
- Assuring quality and compliance of cannabis or cannabis products that are produced, processed, packaged, labelled and stored at Company's Site before they are made available for sale or export;
- Ensuring an effective and robust quality system in compliance with company quality culture, government regulations and international standard requirements.
- Approving methods, processes, procedures, equipment, specifications, materials, chemical and biological substances, ingredients, raw materials, packaging and labelling components that are used for cultivation, production, packaging, labelling, testing and storage of the cannabis, cannabis products or cannabis accessories that contain cannabis, prior to their implementation;
- Approving processes and procedures ensuring compliance in respect of sampling, inspection, testing, approval for sale or export, deviations, non-conformance and out-of-specifications investigations, recall and mock recall, adverse reactions and quality complaints associated with cannabis or cannabis products, and other processes and procedures as it may be necessary;
- Reviewing records associated with production, packaging, labelling, inspection, sampling, testing and storage of cannabis and assessing compliance of every batch or lot of cannabis with respective SOPs, specifications and requirements of applicable regulations and guidelines, prior to availability of the batch or lot of cannabis or cannabis product for sale or export;
- Approving or rejecting every batch or lot of cannabis before it is made available for sale or export, based upon conformance/non-conformance to respective specifications and regulatory requirements (e.g. Cannabis Regulations);
- Approving or rejecting every batch or lot of cannabis or cannabis product received from external vendor or service provider before it is made available for further processing at WeedMD, based upon conformance/non-conformance to respective specifications and regulatory requirements (e.g. Cannabis Regulations);
- Maintaining SOPs and records associated with cannabis in compliance with regulatory requirements and guidelines;
- Initiating necessary processes, investigations, assessments, dispositions and course of actions in respect of returned product;
- Investigating every complaint received in respect of the quality of cannabis and, if necessary, take corrective and preventative measures.
- Initiating necessary processes, investigations and course of actions in respect of pharmacovigilance activities, evaluation and reporting of regulated adverse events and adverse reactions (*);
- Ensuring and maintaining compliance with regulatory requirements and guidelines in respect of recall and mock recall requirements;
- Ensuring that suppliers of cannabis or cannabis products, and contract laboratories are capable of performing the tasks and responsibilities assigned to them;
- Monitoring compliance for training, calibration, sanitation and pest control programs, and other activities which are critical to operation and the GPP/GMP activities, as appropriate;
- Ensuring and maintaining compliance with regulatory requirements and guidelines in respect of batch retention samples;
- Providing Quality representation for GPP, Compliance and RA governed internal and external activities, including inspections by the government agencies and regulatory authorities (Health Canada), as appropriate;
- Establishing Technical Quality Agreements with Associated Companies as appropriate;
- Monitoring compliance regarding control and distribution of quality-related documents;
- Managing the activities of subordinate QA Specialists and Technicians including working with QA Director in performance evaluation, coaching, mentoring, assignment of responsibilities, and commendation/discipline as warranted. Commending and or counseling of QA Specialists and Technicians and administering disciplinary action as necessary.
- Providing necessary reports at request of Director of QA or Senior Management, as necessary.
Qualifications / Skills / Requirements:
- B.Sc. (Pharmaceutical, Pharmacy, Chemistry, Biology, Food) or equivalent in related sciences;
- 3 years demonstrated success working in a Pharmaceutical / NHP / Cannabis industry in Regulatory Affairs / Compliance / Quality or equivalent environment.
- Knowledge of regulations and guidelines pertaining to the business (CA/CR, F&DA/F&DR, GxP, SFCR, HACCP etc.);
- Extensive experience writing SOPs and technical writing and document management;
- Excellent verbal and written communication skills
- Excellent project management and organization skills.
- Ability to maintain security clearance under the Cannabis Regulations;
- Ability to be approved by Health Canada as an Alternate Quality Assurance Person of the Licence Holder;
(*) Investigation, review, evaluation and assessment of the regulated adverse events and adverse reactions, and preparation of the case reports shall be done by a Qualified Health Care Professional who is a member in good standing of a professional medical, nursing, pharmacists' or other health care practitioner association and entitled to provide health care under the laws of the jurisdiction in which the person is located, and other individuals retained by the Licenced Producer who have the appropriate health care education and therapeutic expertise;
WeedMD thanks all applicants for their interest; however, only those selected to continue in the recruitment process will be contacted.
Pursuant to the Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code, WeedMD will accommodate all applicants with disabilities to the point of undue hardship during the recruitment and hiring process. Accommodation will be provided upon request and in accordance with the principles of dignity, individualization, and inclusion. WeedMD will work cooperatively, and in a spirit of respect, with all partners in the accommodation process.
WeedMD is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, colour, race, citizenship, ethnic origin, place of origin, creed, disability, family status, marital status (including single status), gender identity, gender expression, receipt of public assistance (in housing only), sex (including pregnancy and breastfeeding) or sexual orientation.
Job Types: Full-time, Permanent
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Paid time off
- Vision care
- Wellness program
- Bachelor's Degree (required)
- Quality Assurance: 3 years (preferred)