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Added 8 mins ago
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Design Verification Engineer - Memory Subsystem (Vancouver OR Markham)
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- Full-time
…assertions, executing simulations, debugging failures, and driving functional and code coverage…
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Power Builder Developer - 29954-RFR-DTS-074
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Reviews system and integration testing functions.
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Reviews system and integration testing functions.
Added 22 mins ago
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RQ00388 – Solution Architect
S M Software Solutions Inc
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- Full-time
…participate in the analysis, design, development, implementation, testing, and stabilization of technical…
Added 22 mins ago
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RQ00388 – Solution Architect
S M Software Solutions Inc
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- Full-time
…participate in the analysis, design, development, implementation, testing, and stabilization of technical…
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RQ00388 – Solution Architect
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Toronto, ON
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Experience designing detailed functional and technical requirements for new and existing business solutions.
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Solutions Designer – Senior - RQ11671
S M Software Solutions Inc
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Perform engineering testing and investigate issues in field environments.
Added 22 mins ago
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RQ11431 - Specialized IT Consultant – Senior
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- Internship
Update/Create Functional Design Documentation for the Solution.
Added 22 mins ago
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Solutions Designer – Senior - RQ11671
S M Software Solutions Inc
Toronto, ON
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Experience designing detailed functional and technical requirements for new and existing business solutions.
Added 22 mins ago
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RQ11431 - Specialized IT Consultant – Senior
S M Software Solutions Inc
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Update/Create Functional Design Documentation for the Solution.
Added 22 mins ago
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RQ11431 - Specialized IT Consultant – Senior
S M Software Solutions Inc
Toronto, ON
- Internship
Update/Create Functional Design Documentation for the Solution.
Added 37 mins ago
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Senior Software Engineer - Card Network Integration
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- Full-time
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Added 52 mins ago
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Technical Specialist, Senior - Vital Software
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Toronto, ON
- Full-time
The Senior Software Technical Specialist leads the design, development, integration, and testing of complex operationally critical and safety-critical software systems within the railway…
Added 52 mins ago
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Software Architect - Vital Software
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Toronto, ON
- Full-time
The Software Architect leads the design, development, integration, and testing of complex operationally critical and safety-critical software systems within the railway signaling domain. As…
Added 52 mins ago
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Wire Harness/ Bench Build Technician
Actalent
Toronto, ON
- $30 to $35 CAD / hour
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…electrical test benches for software integration validation testing. This role plays a vital part in supporting the development of innovative electric and autonomous driving technologies by…
Added 52 mins ago
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Hardware Engineer
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Ottawa, ON
- $55 to $65 CAD / hour
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Added 52 mins ago
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Added 1 hour ago
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Mechanical Assembler - 1st shift
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Milton, ON
- Full-time
…inspection for conformance to drawings and specifications, functional operation and appearance and making mechanical adjustments as…
Added 1 hour ago
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SAP Utilities FICA Lead
delaware North America
Canada
- Full-time
Develop functional specifications, support testing activities (SIT, UAT, and regression testing), troubleshoot production issues, and provide ongoing application support in a utility…
Added 1 hour ago
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Academic Support Analyst
The University of British Columbia
Vancouver, BC
- $5,692.25 to $8,179.5 CAD / month
- Full-time
…projects, and supports new system and process implementations by testing updates and offering feedback. Building partnerships with stakeholders, this role ensures alignment with academic…
Added 1 hour ago
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Professional Senior, Engineering, Liaison Aircraft System, Operations Support, Global Platforms
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Provide timely engineering-guided support for root cause identification of systems engineering issues encountered during system ground & flight Functional Testing Procedures.
Added 1 hour ago
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Product Manager, Digital Health Technologies
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Closed listing

Nualtis

Quality Assurance Specialist

Montreal, QC, Canada

Full-time

This opening has closed.

The original listing is kept below for reference.

Find open jobs More jobs with this employer

About employer

Job details

Job type: Full-time
Closing date: Nov 4, 2026
Experience: 2–5 years of quality assurance experience within the pharmaceutical, biotechnology, or related regulated industry.
Posting language: English
Posted: Oct 5, 2026

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Original job description

Archived listing. The details below describe a past opening.

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.

About employer

More about this job

Responsibilities

Maintain and improve site quality systems, review and approve quality and manufacturing documentation, and support compliance with cGMP and regulatory requirements. Coordinate supplier and internal audits, support inspections and product commercialization, manage material release activities, and promote quality training and continuous improvement.

Requirements

Requires a bachelor's or master's degree in a scientific discipline or equivalent, with 2–5 years of quality assurance experience in a pharmaceutical, biotechnology, or related regulated industry. Candidates should have GMP manufacturing and packaging experience, knowledge of quality systems and applicable regulations, strong communication and organizational skills, and the ability to work independently and across teams; English-French bilingualism is strongly preferred.

Skills

GMP/cGMP Compliance
Quality Systems
SOP and Documentation Control
Deviation Investigations
CAPA Management
Change Control
Supplier Qualification and Audits
Internal Auditing
Regulatory Inspection Readiness
Batch Record Review
Material Release
AQL Visual Inspection
Pharmaceutical Manufacturing and Packaging
ICH Guidelines
Health Canada and FDA Regulations
Cross-Functional Collaboration

Benefits

Competitive Compensation
Benefits Package
Professional Growth Opportunities
Career Advancement Opportunities

Visa sponsorship

Not detected in the job text

Keywords

Quality Assurance
Quality Operations
Pharmaceutical Manufacturing
Oral Thin Films
GMP
cGMP
GCP
GLP
ICH Guidelines
Health Canada
FDA
Quality Systems
Standard Operating Procedures
Documentation Control
Deviation Investigations
CAPA
Change Control
Annual Product Quality Reviews
Management Reviews
Supplier Qualification
Supplier Audits
Internal Audits
Regulatory Inspections
Customer Audits
AQL Visual Inspections
Material Release
Technology Transfer
Commercialization
Microsoft Office
Continuous Improvement

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