Quality Assurance Associate

Review master and executed batch records, SOPs, STMs, Protocols, Reports, Qualification and validation documents, Analytical data including raw data, ELN, COAs.

Author and review QA documents.

Review external vendors GMP documents.

Support internal and external audit preparation, including document collation, checklist preparation, and follow-up on audit observations.

Participate in investigations, deviations, CAPA, and change control tracking, ensuring timely follow-up and closure support.

Perform Line clearance and environmental monitoring activities.

Support maintenance and improvement of the Quality Management System (QMS) in alignment with GMP and internal quality standards.

Assist in document control activities, including formatting, review coordination, version control, and archival of SOPs, policies, and records.

Help perform quality data trending and analysis (e.g., deviations, complaints, CAPAs) to identify recurring issues and improvement opportunities.

Assist in training coordination, maintaining training records, and tracking completion in the learning management system.

Bachelor or Master degree in discipline related to biologic or pharmaceuticals (biochemistry, biology, chemistry, medical sciences, molecular biology, or relevant field).

2–5 years of experience in pharmaceutical/biotechnology QA.

Knowledge of GMP, GLP, GDP, and regulatory requirements.

Familiarity with FDA, EMA, Health Canada, and other health authority guidelines is an asset.

Familiar with standard analytical lab practices and techniques.

Strong background and interest in molecular biology, biochemistry, and chemistry.