Quality Associate

  • CCS Green
  • Brampton, On, Canada
  • 14 May, 2021

Job Description

Overview:

Our client, a maker of medical and adult-use cannabis products licensed under Canada's ACMPR and C45 regulations, is in need of an experienced Quality Assurance Associate to join their growing Quality team in their Brampton location. This full-time, permanent position offers full benefits and excellent opportunity for career growth. 

 

Responsibilities:

  • Review of batch release and compliance documents required for product release in Canada
  • Maintain supplier master documents, incoming inspection and release documents
  • Maintain knowledge of the regulations and ongoing changes in the cannabis industry
  • Manage 3rdparty lab testing for applicable products and manage confirmatory testing program
  • Co-ordinate QA activities for incoming inspection and product release based on determined priorities
  • Interact with suppliers for receipt of release documents and supporting issues
  • Site Deviations– initiation, investigation, review and maintenance for internal/external issues
  • Site Change Controls– initiate, review and maintain all internal and external change controls
  • CAPA Management– manage site CAPA program and ensure all departments are meeting their obligations for CAPAs based on deviations, complaints, audits, change controls
  • SOP Management– develop new SOP’s and revise existing SOP’s to ensure that they are meeting current corporate and regulatory requirements
  • Assist in investigating all customer complaints, recalls and adverse reactions
  • Returned Goods - Manages QA portion of the returns process including review of documents and final disposition for the returned goods
    • Responsible for requesting/preparation/review of APQR’s
    • Provide SOP training to relevant departments and maintain personnel training records
  • Compile Monthly Inventory Reports and Quarterly Reports
  • Participate in all recall actions as required with regards to inventory management
  • Responsible for the site’s Pest Control Program, Sanitation Program and Environmental Control Program including routine maintenance of microbiology laboratories
  • Microbiological testing of raw materials, in-process, bulk, finished product and stability samples
  • Environmental monitoring including active air, passive air, surfaces, compressed air and non-viable particulate counts
  • Media preparation, sterilization, QC testing of culture media for sterility and growth promotion tests
  • Operation and maintenance of microbiology laboratory equipment
  • Document test results as per SOP and GMP
  • Recognize OOS or OOT results and under the direction of the Supervisor assists in the completion of lab investigations
  • Complete all GMP documentation correctly and in a timely manner

Qualifications:

  • Post-secondary degree or diploma in a related field
  • 3+ years of QA experience, preferably from within a pharmaceutical manufacturing facility