QA Associate
Up Cannabis
Hamilton, ON

Job Description

Up Cannabis is a federally licensed producer of cannabis with an operational facility in Brantford, Ontario and a new facility currently under construction in Beamsville, Ontario. Up is wholly owned by Newstrike Brands, which is a publicly traded company on the TSXV and trades under the ticker symbol "HIP".

General Responsibilities:

Reporting directly to the Director QA, this role is responsible for ensuring consistent quality of product. The QA Associate must have a deep understanding of compliance requirements that meet or exceed Health Canada as well as internal requirements.

Key Responsibilities:

  • Quality System maintenance and management
  • Review and control of Canadian printed packaging components (including master label artwork);
  • Documentation review of all GPP documents;
  • Review and control of Canadian production and packaging documents;
  • Analytical finished product testing and Finished Product Specifications;
  • Finished product release to Canadian distribution system based on conformance of finished product to all manufacturing and Quality Control/Assurance standards for the Regulated
  • Products and all applicable GPPs, which includes: Batch Documentation Review, Certificate of Analysis Review, Label Review, Sample Handling and Release of Finished Product;
  • Handling and review of any necessary investigations arising out of complaints regarding quality;
  • Handling and review of any product retrievals or recalls;
  • Ensuring all levels of change are evaluated and documented;
  • Investigate Out of Specification results;
  • Coordinating and overseeing destructions;
  • Investigations associated with Pharmacovigilence Activities (Adverse Events);
  • Validation Protocols and Reports including but not limited to, Process Validation, Cleaning
  • Validation and Method Transfers/Validations;
  • Annual Product Quality Review creation and maintenance

Stability Program Work including:

  • Review and assess for compliance data from stability programs for the Regulated Products;
  • Set-up and Review of Stability Programs including Stability specifications
  • Write, review, revise and maintenance of Standard Operating Procedures as they pertain to the production, distribution and sale of the Regulated Products in Canada;
  • Preparation and maintenance of regulatory documents (i.e.: Producers Licence) as they relate to the Regulated Products;
  • Audits of sites on behalf of the Licensed Producer;
  • Supervision and Representation at Health Canada Inspections on behalf of the Licensed Producer; and
  • Provide GPP training to staff members.

Requirements:

  • Bachelor of Science
  • Certificate in Pharmaceutical Regulatory Affairs & Quality Operations preferred
  • 2-3 years relevant experience with in the pharmaceuticals, biotech or healthcare industries in regulatory/compliance
  • Strong knowledge of current Canadian GMP regulations and guidelines
  • Previous experience writing SOPs and technical writing and document management
  • Proficient in the use of Microsoft Office suite
  • Ability to work independently, and as part of a team and collaboratively across the organization
  • Ability to prioritize and schedule daily activities, manage multiple priorities, and requests under tight time constraints
  • Excellent analytical and problem solving skills
  • Outstanding communication skills, written and verbal
  • Clean police background check
  • Patient/Customer focus, results oriented with excellent organizational skills

Job Type: Full-time

Experience:

  • Quality Assurance: 4 years (Preferred)