Quality Assurance Specialist

4 weeks ago

Canada IMV Inc. Full time

Position Overview

As a vital member of the Quality Assurance team at IMV Inc., reporting directly to the Associate Director of Quality Assurance, your primary responsibility will be to uphold the integrity of our processes while enhancing our Quality Management System.

Key Responsibilities

  • Collaborate with various departments to ensure adherence to internal Standard Operating Procedures (SOPs), documented protocols, and established quality standards.
  • Examine Good Manufacturing Practice (GMP) documentation, including batch records, label proofs, GMP specifications, and certificates, while preparing release documentation for QA Management approval.
  • Draft and review SOPs, change controls, qualification reports, specifications, and protocols as necessary.
  • Conduct vendor qualification processes, including initial assessments and ongoing evaluations.
  • Assist in maintaining document management and training for quality-controlled documents within the electronic Quality Management System (eQMS).
  • Manage paper filing systems where applicable.
  • Deliver quality training on Quality Management Systems and processes, and support annual GMP training initiatives.
  • Facilitate internal and external audits.
  • Help address findings from external, internal, and regulatory audits.
  • Ensure timely resolution of quality events through collaboration with relevant departments.
  • Oversee the procedures related to the initiation and reporting of deviations, incidents, complaints, self-inspections, and Corrective and Preventive Actions (CAPAs).
  • Provide oversight for the calibration and validation programs of equipment and systems in partnership with relevant departments, ensuring quality management of equipment.
  • Perform additional clerical, laboratory, administrative, and miscellaneous tasks as directed by the Associate Director of Quality Assurance.

Qualifications

To excel in this role, you should possess:

  • Exceptional attention to detail and strong organizational skills.
  • The ability to thrive in a fast-paced environment while consistently delivering results on schedule.
  • Strong written and verbal communication abilities.
  • A self-motivated approach with the capacity to work independently.
  • Effective interpersonal skills and the ability to work collaboratively within a team.
  • Analytical thinking skills, enabling you to prioritize tasks and solve problems efficiently.
  • Capability to manage multiple tasks and adapt to changing priorities under pressure.
  • Effective training and presentation skills.

Education and Experience

  • A post-secondary diploma or related scientific degree is required (BSc. or higher in Chemistry, Biochemistry, or Microbiology).

Additional Qualifications

  • Certification in pharmaceutical training or equivalent is advantageous.

Experience and Skills

  • A minimum of 3 years of experience in Quality Assurance and Compliance within the pharmaceutical sector.
  • Familiarity with FDA, Health Canada, EU GMP, ICH guidelines, and regulatory standards.
  • Experience with GMP operations and a solid understanding of quality assurance and control programs, including Quality Management Systems.
  • Knowledge of Good Documentation Practices.
  • Proficiency in computer applications (MS Office Suite: Word, Excel, Access, PowerPoint).

Preferred Qualifications

  • Understanding of Good Clinical Practices (GCPs).
  • Experience in engaging with Regulatory Agencies during audits and correspondence.
  • Experience working with an eQMS for document management and training.

Core Competencies

  • Detail Orientation
  • Critical Thinking
  • Organizational Skills
  • Communication Skills

About IMV Inc.

IMV Inc. is a pioneering clinical-stage pharmaceutical company focused on developing innovative T cell-targeted immune therapies for cancer treatment. Our groundbreaking delivery platform (DPX) facilitates the generation of targeted immune cells directly within the human body, enhancing the capability to combat cancer effectively. Our lead drug candidate, Maveropepimut-S (DPX-Survivac), has shown promising results in advanced recurrent ovarian cancer and Diffuse Large B Cell Lymphoma (DLBCL) through successful Phase 1/1b trials.

Our Commitment

At IMV, we uphold high standards and aspire to achieve remarkable outcomes. Our technology and drug candidates are instrumental in driving our mission forward, and our dedicated team is the cornerstone of our success.

Join Us

We value high performance and support our employees in achieving their professional goals while enjoying a fulfilling life. Our corporate culture fosters camaraderie and teamwork, essential for overcoming the challenges in our industry.

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