Quality Assurance Specialist

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 cGMP 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 cGMP 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/cGMP 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/cGMPs; 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, PowerPoint, 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.

Apply today and help drive quality excellence in pharmaceutical operations.