Quality Assurance Associate

Job summary

Maintain controlled quality documentation and electronic quality records, ensuring compliance with Good Documentation Practices and applicable GMP requirements. Support investigations, CAPA, change control, audits, batch and product quality reviews, and cross-functional efforts to resolve quality issues and improve processes.

Job details

Position: Quality Assurance Associate Location: Brantford, ON (On-site) Pay Rate: $30/hour Job Type: 6-month Contract - Potential for Extension Posting Type: Open Vacancy Do you have a passion for quality, an eye for detail, and experience working in a regulated manufacturing environment? Here's your opportunity to put your expertise to work! Our client is looking for a Quality Assurance Associate to join their team in Brantford. This role is ideal for a quality professional with pharmaceutical, radiopharmaceutical, or medical-device experience who enjoys solving problems, strengthening quality processes, and ensuring documentation and procedures meet regulatory standards. You'll play an important role in maintaining quality systems, supporting investigations, and working alongside Quality Control, Quality Assurance, and Manufacturing teams to help keep operations compliant and products up to standard. If you're looking to build on your GMP experience and expand your knowledge of quality systems, this could be an excellent next step. What's in It for You? - $30/hour with potential for contract extension - Hands-on experience in a regulated manufacturing environment - Exposure to pharmaceutical GMP or medical-device quality systems - Opportunity to work with deviations, investigations, CAPA, and change control - Experience using electronic quality systems and controlled documentation - Collaboration with Quality and Manufacturing teams Key Responsibilities: - Review and maintain controlled quality documentation, including SOPs, batch records, forms, logbooks, and other quality records. - Support deviation and non-conformance investigations by gathering evidence, reviewing documentation, identifying potential root causes, and preparing reports. - Assist with CAPA activities, including documenting corrective actions, tracking implementation, and supporting follow-up. - Support change control processes and maintain accurate quality records. - Ensure documentation meets Good Documentation Practices (GDocP) and applicable GMP requirements. - Maintain and update quality records using electronic quality management systems (eQMS). - Support internal audits, regulatory inspections, and audit-readiness activities. - Assist with product quality reviews, batch documentation review, and release-related activities as required. - Collaborate with Quality Control, Manufacturing, and other departments to address quality issues and support timely resolution. - Track quality data, maintain compliance records, and contribute to continuous improvement initiatives. Qualifications & Experience: - Experience in a pharmaceutical, radiopharmaceutical, medical-device, or similarly regulated manufacturing environment. - Working knowledge of GMP requirements, preferably Canadian drug GMP or equivalent FDA drug GMP. - Experience supporting deviations, investigations, CAPA, and quality documentation. - Familiarity with Good Documentation Practices (GDocP), SOPs, and controlled records. - Experience using an eQMS or electronic quality system, such as TrackWise, MasterControl, QT9, or a similar platform. - Exposure to change control, batch record review, product release, and audit support is an asset. - Experience with ISO 13485 and/or MDSAP is an asset. - Laboratory or analytical testing experience with techniques such as HPLC, GC, IR, or titration is an asset but not required. - Strong attention to detail, documentation, organization, and problem-solving skills. - Ability to work collaboratively with Quality and Manufacturing teams in an on-site environment. - Diploma or degree in Science, Chemistry, Life Sciences, Pharmaceutical Sciences, Quality Assurance, or a related field. PLEASE NOTE THAT APPLICANTS WHO APPLY DIRECTLY TO THE POSTING WILL BE REVIEWED! REFER A TEMP HIRE AND EARN A BONUS! For details, click here. All applications are reviewed by our recruitment team, and hiring decisions are made by people. We may also use AI-enabled tools to support parts of the application review process. #tor1

What you’ll do

Maintain controlled quality documentation and electronic quality records, ensuring compliance with Good Documentation Practices and applicable GMP requirements. Support investigations, CAPA, change control, audits, batch and product quality reviews, and cross-functional efforts to resolve quality issues and improve processes.

Requirements

Candidates should have experience in a regulated manufacturing environment and working knowledge of GMP, quality documentation, deviations, investigations, and CAPA. A science-related diploma or degree is requested; familiarity with eQMS platforms is expected, while change control, batch review, audit support, ISO 13485/MDSAP, and laboratory testing experience are assets.

Benefits

• Potential Contract Extension
• Hands-On Experience In A Regulated Manufacturing Environment
• Exposure To Pharmaceutical GMP Or Medical-Device Quality Systems
• Experience With Deviations, Investigations, CAPA, And Change Control
• Experience Using Electronic Quality Systems And Controlled Documentation
• Collaboration With Quality And Manufacturing Teams

Listed skills

• Root Cause Analysis · Preferred
• Continuous Improvement · Preferred
• Problem solving · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• GMP Compliance
• Good Documentation Practices
• Quality Documentation
• Deviation Investigations
• Root Cause Analysis
• CAPA
• Change Control
• Electronic Quality Management Systems
• SOP Management
• Batch Record Review
• Audit Support
• Regulatory Inspection Readiness
• Product Quality Reviews
• Quality Data Tracking
• Continuous Improvement
• Problem-Solving

Job areas

• Manufacturing
• Healthcare
• Science & Research

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