23 Oct
|
Nutrasource
|
Guelph
23 Oct
Nutrasource
Guelph
Company Overview
SGS Nutrasource is a global contract research organization (CRO) and consulting firm specializing in regulatory affairs, clinical trials, analytics, and product certifications for health products. Since 2002, we’ve grown from a small team to an industry leader, partnering with clients worldwide to bring protected, effective, and innovative products to market.
Our Quality Assurance (QA) team supports all areas of the business, ensuring our work meets the highest standards of GxP compliance and regulatory expectations.
Position Overview The Quality Assurance (QA) Associate will support all functional areas of Nutrasource, including the CRO, Clinical Trial Site, Certifications & Analytics, R&D;, and GLP-related activities.
You will conduct audits, provide GCP/GLP oversight, and help develop and maintain our quality systems to ensure adherence to Nutrasource Work Instructions, SOPs, policies, and applicable regulations/guidelines. This role is ideal for someone who enjoys a mix of hands-on auditing, cross-functional collaboration, and continuous improvement.
Primary Responsibilities
- Conducts QA audits (Investigator Site, Vendor, Internal, For-cause/directed) and generates audit reports.
- Communicates audit results to management and external stakeholders and follows up to ensure corrective and preventive actions are implemented and closed.
- Assists the QA lead with annual audit planning and development of the Audit Schedule.
- Reviews study protocols, Informed Consent Forms, Investigator’s Brochures, Assent Forms, and other key study documents as needed.
- Represents QA on project/study teams, providing GCP/GLP and compliance guidance.
- Interfaces professionally with regulatory bodies, clients, investigators, and internal project teams.
- Ensures timely escalation of quality issues, including potential misconduct or significant deviations related to projects/products.
- Develops/enhances QA procedures, tools, and templates to ensure consistency.
- Assists with controlled document preparation and issuance.
- Verifies training documentation for Nutrasource employees for completeness and compliance.
- Manages or assists with client audits and regulatory inspections, including scheduling, preparation, hosting, response drafting, and follow-up on commitments.
- Provides training, inspection preparation, and QA support to teams across the organization.
- Promotes GxP compliance and quality culture throughout the company.
- Performs other QA-related duties as required and as training and experience allow.
- Maintains an attitude and philosophy consistent with the Company’s standards and values.
Core Competencies
- Knowledge and experience in GxP and QA principles, processes, and industry standards.
- Knowledge of ICH E3, E6, and E8; Health Canada Food & Drug Regulations (Part C, Division 5); applicable 21 CFR Parts; GLP regulations; and OECD guidelines, with the ability to apply them in practice.
- Familiarity with Canadian Natural Health Product Regulations and Cannabis Regulations is an asset.
- High attention to detail with the ability to understand how issues impact the bigger picture.
- Excellent organizational and time-management skills.
- Highly collaborative; strong team player who builds effective working relationships.
- Strong written and verbal communication skills.
- Experience with risk management, deviation investigations, and CAPA management concepts.
Qualifications
- Post-secondary degree or diploma in a life science or related discipline (or equivalent combination of education and experience).
- Experience in a QA role within a CRO, clinical research site, pharmaceutical, biotechnology, or related regulated environment is preferred.
- Working knowledge of GCP, GLP, and other applicable health product regulations.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Ability to manage multiple priorities and meet timelines in a fast-paced environment.
Job Type: Full-time Pay: $50,000.00-$60,000.00 per year
Benefits
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
Work Location: In person
📌 Quality Assurance Associate (Guelph)
🏢 Nutrasource
📍 Guelph