Job Summary The Quality Assurance Associate supports Quality Operations, Quality Systems, and Compliance activities to ensure adherence to Good Manufacturing Practices (GMP) and the organization's Quality Management System (QMS).

This role is responsible for quality oversight, document control, change management, investigations, CAPA administration, batch record review, audit support, supplier quality management, and product release activities within a regulated manufacturing environment.

Key Responsibilities Support quality incident programs, including deviations, laboratory investigations, complaints, supplier-related issues, and Out-of-Specification (OOS) investigations.

Review, assess, and approve minor incidents and Phase I OOS investigation outcomes while participating in major investigations.

Participate in internal audit programs and support external customer, regulatory, and supplier audits.

Manage document control activities and lead updates to Standard Operating Procedures (SOPs).

Review and support change control requests across departments to ensure GMP compliance.

Support Annual Product Review (APR) programs, Quality System Reviews (QSR), metrics reporting, and quality scorecards.

Monitor and enforce GMP compliance across manufacturing, laboratory, and support operations.

Support supplier qualification, monitoring, and supplier quality management programs.

Conduct facility inspections, room release activities, and compliance assessments.

Prepare and review validation, qualification, and quality-related protocols and reports.

Issue, review, maintain,



and archive Quality Control documentation and notebooks.

Deliver GMP and SOP training to employees across multiple departments.

Manage product label master files and support label creation and revision activities.

Support Corrective and Preventive Action (CAPA) programs and effectiveness tracking.

Review and approve analytical validation data, protocols, reports, and associated documentation.

Support analytical method lifecycle management, process transfers, and validation activities.

Participate in pest control monitoring, inspections, and investigations.

Perform batch record review and GMP data review for critical raw materials, active pharmaceutical ingredients (APIs), and finished products.

Support product release activities following successful completion of required release training.

Review and approve batch record creation, revisions, and process lifecycle documentation.

Participate in SOP lifecycle management and quality review/approval processes.

Required Qualifications Post-secondary education in a related field.

Minimum of 3 years of experience within a pharmaceutical, biotechnology, food, or regulated manufacturing environment.





At least 1 year of direct experience working within a Quality Assurance or Quality Unit function.

Knowledge of GMP regulations, quality systems, and compliance requirements.

Experience with investigations, CAPA, change control, document management, and batch record review.

Strong attention to detail and ability to maintain accurate documentation.

Excellent written and verbal communication skills.

Strong organizational, analytical, and problem-solving abilities.

Ability to work independently and as part of a cross-functional team.

Preferred Qualifications Bachelor's degree in a Scientific discipline such as Chemistry, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, or related field.

Experience with supplier quality management and audit programs.

Knowledge of validation, qualification, analytical method lifecycle management, and process transfer activities.

Experience supporting product release functions within a GMP-regulated environment.

Robust presentation and training delivery skills.

Demonstrated ability to prioritize multiple projects and deadlines effectively.

Certifications GMP Training or Certification preferred. ASQ Certified Quality Auditor (CQA), Certified Quality Improvement Associate (CQIA), or similar quality certification preferred.

Additional pharmaceutical, biotechnology, or quality management certifications are considered an asset.

Education: Bachelors Degree Certification: ASQ Certified Quality Auditor

📌 Quality Associate (Charlottetown)
🏢 Compunnel
📍 Charlottetown