Quality Assurance Specialist

January 5 2018
Categories Quality assurance and control - Validation
Quebec, QC

Description

ROLE AND RESPONSIBILITIES

Reporting to the Manager–Quality Assurance-Québec City, you are responsible for all quality-related activities aimed at ensuring maintenance at all times of Héma-Québec's status with the various regulatory and accreditation agencies (Health Canada, FDA, AABB, AATB, ISO 15189, ISO13485, CSA and others). You work as part of a client-focused team that is fully responsible for quality assurance files, including non-compliances and controlled documents, as well as responses to internal and external audits.

More specifically, you:

  • Revise, approve and follow up change controls, non-compliances, complaints, problem reports, product and material withdrawals and recalls, and adverse reactions, making sure to include the supporting documentation;
  • Take part, as a quality systems specialist, in various projects and meetings related to Héma-Québec's regulatory activities.

REQUIREMENTS

  • University degree in the sciences (chemistry, biology, biochemistry);
  • Minimum of 3 to 5 years of experience in quality assurance or regulatory affairs;
  • Good command of French and English, both spoken and written;
  • Very good knowledge of Microsoft Office Suite software.

DESIRED ATTRIBUTES

  • Recognized communication and interpersonal relationship skills;
  • Demonstrated self-sufficiency, organizational skills and ability to adapt;
  • Good knowledge of the regulatory environment;
  • Expertise in biological analysis methods, including validation, as well as expertise in cell biology and molecular biology;
  • Sound knowledge of Canadian and American laboratory best practices (LBP) and manufacturing best practices (MBP) is a major asset.
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