Quality Assurance Specialist in Montréal

• Quality Assurance Specialist (Quality Operations)
• Nualtis
• Saint-Laurent, QC (On-site)

Job Type

Full-time · Associate / Mid‑Senior level

Department

Quality Operations

Reports to

VP Quality

About the job

About Nualtis

Nualtis is a pioneering drug delivery company specializing in the development and manufacturing of oral thin films.

We are currently scaling from R&D into commercial-scale production at our state-of-the-art Montreal facility.

With 20+ years of expertise and a tight-knit team of 30, we are looking for a proactive individual to join our growing team and contribute to our ongoing success.

Position Summary

We are seeking a motivated and detail-oriented Quality Assurance Specialist to join our Quality Operations team.

The successful candidate will play a key role in maintaining and improving quality systems while ensuring compliance with Health Canada, FDA, and c GMP requirements for both developmental and commercial pharmaceutical products.

The QA Specialist will collaborate cross-functionally with Manufacturing, Packaging, Quality Control, Product Development, Supply Chain, and other departments to support quality initiatives, regulatory compliance, inspection readiness, and continuous improvement activities.

Key Responsibilities

• Quality Systems & Compliance
• Ensure quality system activities are implemented and maintained consistently across all site departments.
• Serve as the primary Quality Systems contact for SOP and form implementation.
• Write, review, revise, and maintain quality system documentation, including SOPs, forms, protocols, and reports.
• Ensure compliance of documentation systems with applicable c GMP requirements.
• Monitor implementation of regulatory inspection commitments and actions within agreed timelines.
• Control documentation, issue working copies, verify raw data, and manage archival of hard-copy records.
• Quality Review & Approval
• Review and approve deviations, investigations, change controls, and CAPAs.
• Review and approve SOPs, protocols, reports, testing certificates, batch records, and associated manufacturing documentation.
• Support Annual Product Quality Reviews (APQRs) and Management Reviews.
• Supplier & Audit Management
• Manage and maintain supplier/vendor qualification, approval, and audit programs.
• Coordinate and support external audits of suppliers and service providers.
• Conduct internal audits as required.
• Participate in regulatory agency inspections and customer audits, including preparation, hosting, and follow-up activities.
• Quality Operations Support
• Conduct GMP facility tours and compliance inspections.
• Prepare quality and compliance metrics and present summary reports to management.
• Perform AQL visual inspections and complete required documentation.
• Manage material inventory lifecycle activities and material release processes.
• Review and approve material releases in accordance with established procedures.
• Support Product Development teams during product development, scale-up, technology transfer, and commercialization activities.
• Training & Continuous Improvement
• Coach and support production and operations personnel on GMP/c GMP requirements and quality-related issues.
• Foster a culture of quality, compliance, and continuous improvement throughout the organization.
• Build and maintain positive working relationships with internal stakeholders and external partners.
• Perform all duties in compliance with applicable regulatory, quality, and safety requirements.
• Carry out additional responsibilities as assigned.

Qualifications

Education

• Bachelor's or Master's degree in a Scientific Discipline (Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field) from a recognized university or equivalent.

Experience

• 2–5 years of quality assurance experience within the pharmaceutical, biotechnology, or related regulated industry.
• Experience supporting GMP manufacturing and packaging operations.
• Experience with quality systems, investigations, CAPA management, change control, and documentation control.
• Knowledge & Skills
• Strong knowledge of: GMPs/c GMPs; GCPs and GLPs; ICH Guidelines; Health Canada and FDA regulatory requirements
• Understanding of pharmaceutical manufacturing and packaging processes.
• Proficiency in Microsoft Office applications (Word, Excel, Power Point, Outlook).
• Strong analytical, organizational, and problem-solving skills.
• Excellent written, verbal, and presentation skills.
• Bilingualism (English and French) is strongly preferred.
• Ability to work independently and effectively within cross-functional teams.
• Demonstrated ability to manage multiple priorities in a fast-paced environment.

Why Join Us?

• Work in a dynamic and growing pharmaceutical environment.
• Contribute directly to product quality, patient safety, and regulatory compliance.
• Collaborate with experienced professionals across Quality, Manufacturing, and Product Development.
• Opportunities for professional growth and career advancement.
• Competitive compensation and benefits package.
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