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Quality Assurance Specialist

76 200 - 110 100$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Canada
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Assurance Specialist (Biopharmaceutical Manufacturing): Providing quality oversight for shop-floor manufacturing activities and licensed products with an accent on cGMP compliance, deviation investigations, and science-based batch decisions. Focus on leading root-cause analysis and CAPA activities, reviewing GxP documentation, supporting audits and inspections, and driving quality improvements.

Location: Toronto, ON; onsite

Salary: 76,200.00–110,100.00 annually

Company

hirify.global is a global biopharmaceutical company developing medicines and vaccines, with a focus on human health and scientific innovation.

What you will do

  • Provide quality oversight and guidance for shop-floor and operational activities within the Formulations, Filling and Packaging area.
  • Coach production staff and promote compliant execution, strong process knowledge, and risk-based decision-making.
  • Lead and support deviation investigations, including problem definition, root-cause analysis, CAPAs, and compliance-based batch decisions.
  • Review and approve deviations, SOPs, CAPAs, change controls, batch records, logbooks, protocols, reports, and other GxP documentation.
  • Represent Quality Assurance on change control, deviation review, and quality improvement committees.
  • Participate in self-inspections, internal reviews, external audits, regulatory inspections, gap remediation, and site projects.

Requirements

  • Bachelor of Science degree and 3 or more years of relevant experience in a pharmaceutical or biological manufacturing environment.
  • Strong leadership, management, influencing, and communication skills.
  • Extensive knowledge of cGMPs, compliance trends, inspections, and audits.
  • Strong problem-solving, root-cause analysis, and investigation skills.
  • Experience with continuous improvement methodologies and risk-based approaches.
  • Ability to work onsite in Toronto, ON.

Culture & Benefits

  • Supportive, future-focused environment centered on scientific innovation and improving patient health.
  • Opportunities for career growth through promotion or international and lateral moves.
  • Employee rewards and benefits programs.
  • Healthcare, prevention, and wellness benefits for employees and families.
  • Equal opportunity workplace with accommodation available during the recruitment process.

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