Seeking a bilingual Quality Assurance Associate, Huntingdon, QC

4 mins read

For this week’s Job of the Week, Cannabis At Work is seeking a bilingual Quality Assurance Associate for their client, a cannabis facility in Huntingdon, QC. This individual will participate in the completion of milestones associated with specific projects and support ongoing SOP Management, Management of Deviations, CAPAs, Change Management, Annual Product Reviews, and general quality management systems responsibilities in support of the manufacture, package, and release of commercial products.

Responsibilities

  • Generate, maintain, and manage Quality Assurance and eQMS standard operating procedures (SOPs)
  • Act as Subject Matter Expert (SME) for Quality Risk Management
  • Review deviation and investigation records, including tracking, follow-up, and reporting/trending; ensure GMP/GPP/GDP and deviation procedures are followed
  • Review Corrective and Preventative Actions (CAPA), including tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
  • Work with all departments to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations
  • Help the Quality Hold and Release Manager with the review of batch records for product release
  • Oversee controlled document and system changes and perform detailed impact analysis to ensure all necessary GMP/GPP and qualification action items have been added to the change controls, as well as executed
  • Collaborate and liaise with the business to review and manage Change Control Requests; ensure GDP and change management procedures are followed
  • Assist with monitoring all internal QMS compliance through performing internal audits, including production, facilities, validation, and laboratories
  • In collaboration with Quality colleagues, identify areas for continuous improvement within the eQMS; collaborate significantly with cross-functional groups, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs, on quality assurance matters
  • Complete APR reports in accordance with the schedule, gathering information available from batch records, investigations, product changes, complaints, etc.
  • Cross-train with other QA Associates/Specialists
  • Responsible for Logbook issuance, control, and review
  • File and maintain controlled documents
  • Other duties as assigned.

Qualifications

  • 3+ years of GMP/GPP/GDP-related experience in pharmaceutical or healthcare manufacturing facilities
  • Bachelor’s degree or diploma in Chemistry, Biology, Engineering, or related field
  • Thorough knowledge of GMP/GDP/GPP international regulatory compliance in addition to Regulatory/Operations experience in a GMP/GPP environment
  • Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment
  • Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors
  • Excellent written and verbal communication skills
  • Excellent problem-solving skills
  • Bilingualism in French and English is required.

See the full listing and connect with the Cannabis At Work team about this position.


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