2 дня назад
Specialist, Quality Assurance (GMP Manufacturing)
84 731 - 93 650CAD
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Specialist, Quality Assurance (GMP Manufacturing): Providing real-time quality oversight for GMP manufacturing operations at the Laval site with an accent on compliance, deviation management, facility readiness, and contamination control. Focus on making quality decisions during rotating shifts, reviewing manufacturing documentation, supporting audits and inspections, and strengthening quality systems through continuous improvement and digital and AI-enabled tools.
Location: Laval, Canada; hybrid 70/30 work model with 70% in-office collaboration
Salary: $84,730.88–$93,649.92 annual base pay, plus potential discretionary bonus, incentive compensation, or equity award.
Company
is a biopharmaceutical company developing an mRNA technology platform and medicines to transform healthcare.
What you will do
- Provide real-time, on-the-floor Quality support for GMP manufacturing operations and monitor activities for compliance.
- Make quality decisions, identify risks and gaps, escalate critical issues, and support troubleshooting across rotating shifts.
- Coordinate and approve deviation and minor change control records, review batch records, and support material release and product disposition.
- Maintain quality documentation, logbooks, laboratory notebooks, archival records, traceability, and data integrity.
- Oversee contamination control, environmental monitoring, facility sanitization, internal audits, and regulatory inspections.
- Champion continuous improvement, quality culture, training coordination, and the use of digital and emerging AI-enabled tools.
Requirements
- Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmacy, or a related science field, or an equivalent combination of education and experience.
- 3–5 years of pharmaceutical or related experience with an emphasis on current Good Manufacturing Practices.
- Ability to develop a strong understanding of GxP regulations and apply cGMP, SOP, documentation, and data integrity requirements.
- Fluency in French and English as working languages.
- Willingness and ability to work rotating morning, afternoon, and night shifts at the Laval site.
- Ability to make independent decisions, collaborate cross-functionally, and escalate issues appropriately.
Culture & Benefits
- In-person collaboration model focused on innovation, teamwork, mentorship, and quality culture.
- Healthcare and voluntary benefits, plus fitness, mindfulness, and mental health resources.
- Family-building support covering fertility, adoption, and surrogacy.
- Paid time off including vacation, holidays, volunteer days, sabbatical, recharge days, and a discretionary year-end shutdown.
- Savings and investment programs, along with location-specific benefits and extras.
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