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Bioanalytical quality assurance inspector

Immuni T

This is a Full-time position in Montréal, QC posted February 10, 2019.

We are looking for candidates with extensive knowledge of bioanalysis and Good Laboratory Practice to build and maintain a culture of quality at Immuni T.

The candidate will develop documents for quality that are clear, consistent, easy to use, and easy to understand; that comply with GLP; and that meet assigned deadlines. They will gather and synthesize information from a variety of scientific, regulatory, and other sources as well as internal subject matter experts. The candidate will also review existing documents, suggest constructive changes based on their regulatory and operational knowledge, incorporate changes from subject matter experts, and publish revised documents within the document control system.

The candidate will also perform documented process-, facility-, and study-based inspections to ensure compliance with SOPs, policies, and regulations and participate in instrument validation projects.

The candidate may also be asked to give personnel training.

  • BSc
  • Significant bioanalytical experience in CRO setting
  • Strong knowledge of GLP regulations (FDA, OECD), including relevant guidances and industry best practices
  • Bilingual with excellent written English
  • Strong computer skills
  • Ability to manage several projects simultaneously and to adapt to changing priorities
  • Ability to execute tasks with minimal supervision
  • Attention to detail
  • GCP, immunology, large molecule bioanalysis, flow cytometry, cell culture knowledge helpful

Skills Required

  • Education level: University
  • Work experience (years): 3-5 years

Package

Salary: N/D