Job Description

The Quality Assurance (QA) Associate will support all functional areas of Nutrasource including CRO, Clinical Trial Site, Certifications & Analytics, R&D, and animal services including GLP related QA activities. The QA Associate will utilize audit and inspection intelligence to assure adherence to respective GxP requirements. The QA Associate will support quality audits and document control. With regards to audits, they will conduct audits internally and assist with the conduct of external audits to ensure compliance with company policies, SOPs, work instructions and regulations. Within document control, the QA Associate will manage document change control, track training, and assist with implementation of the electronic quality management system.Primary Responsibilities:

• Conducts QA audits (Investigator Site, Vendor, Internal, For-cause/directed audits), generates audit reports, communicates results to relevant management and external stakeholders, and interacts with various teams to ensure corrective and preventive actions are taken to bring QA observations to closure as applicable

• Assists the QA in-charge with audit planning for publication in the Annual Audit Schedule

• Reviews study protocols, Informed Consent Forms, Investigators Brochures, Assent Forms, etc. as needed

• Represents QA and provides QA guidance for project/study teams, including GCP/GLP compliance input and guidance

• Interfaces professionally with relevant stakeholders, including regulatory bodies, clients and internal project teams

• Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products

• Develops/enhances QA procedures and tools to ensure consistency

• Assists with controlled documents preparation and issuance

• Verifies training documentation for Nutrasource employees

• Manages or assists with managing client audits and regulatory inspections, including scheduling, preparation activities, hosting, responses to audit/inspection reports, and follow-up on commitments made during the audit/inspection and in the audit/inspection report response

• Provides training, inspection preparation and support as needed to the organization

• Promotes GXP Compliance across the organization

• Performs other duties as may be required and as training and experience allow

• Maintains an attitude and philosophy consistent with the Company's standards

Core Competencies:

• Knowledge and experience in GXP and QA principles, processes & industry standards

• Knowledge of ICH E3, E6 and E8; Health Canada Food & Drug Regulations, Part C, Division 5; and applicable 21 CFR Parts; applicable GLP regulations and the ability to apply them to practical situations

• Familiarity with Canadian Natural Health Product Regulations and Cannabis Regulations

• High attention to detail as well as a grasp of how an issue impacts the larger picture

• Excellent organizational skills

• Highly collaborative; a strong team player

• Effective written and verbal communicate skills

• Experience working with risk management and CAPA management concepts

• Ability to work independently with efficiency and accuracy

• Excellent interpersonal and public relation skills

• Strong knowledge of MS Office and excellent computer skills

Education & Experience:

• Minimum Bachelor's degree in a scientific discipline or equivalent qualification

• Minimum of 1-2 years experience of Quality assurance in pharmaceuticals and/or natural health product setting

Preference will be given to candidates with GCP and/or in vivo GLP experienceJob Type: Full-timeAdditional pay:

• Bonus pay

Benefits:

• Dental care
• Extended health care
• Vision care

Schedule:

• 8 hour shift