QA Specialist

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

As a QA Specialist, you will act as a key Quality partner for cross-functional teams (including Manufacturing, QC, Validation, Technical Services, Supply Chain, and R&D), ensuring strict adherence to GMP requirements and internal procedures. Your role is central to operational compliance, coaching, documentation oversight, and regulatory readiness. With deep expertise in quality systems and a hands-on approach, you are a trusted resource for the business.

Key Responsibilities

• Serve as the primary QA point of contact for assigned operations, ensuring compliance with GMP standards and internal procedures.
• Ensure data integrity and traceability in digital and paper systems (e.g., SAP, LIMS, TrackWise, Discoverant).
• Approve creation of new GMP article codes, ensuring alignment with procedures and systems.
• Coach operational teams in GMP standard methodologies, translating regulatory requirements into practical mentorship.
• Review and approve GMP documentation (batch records, validation reports, sampling plans, specifications, calibration records, BOMs, MBRs, etc.).
• Coordinate QA elements of batch release, including BR assessments and raw material release without QC testing.
• Participate in and lead on-site audits and inspections (internal, external, regulatory), representing QA topics and documentation.
• Support deviation, CAPA, and change control investigations and ensure timely and thorough documentation.
• Maintain QA oversight of equipment qualification, process validation, and environmental compliance in GMP areas.
• Contribute to continuous improvement initiatives, document lifecycle management, and GMP training.
• Promote teamwork and positive attitude

Qualifications

• Master’s degree in Biology, Biochemistry, Chemistry, or a related scientific field.
• Thorough with strong documentation and problem-solving abilities.
• Strong working knowledge of SAP and LIMS (asset).
• At least 5 years of experience in pharmaceutical QA, preferably in an aseptic manufacturing environment.
• Proven experience working in GMP-regulated environments.
• Fluent in French and English (spoken and written).
• Excellent communication, analytical, and coaching skills.

What We Offer

• A dynamic, multi-product biopharmaceutical site supporting both clinical and commercial manufacturing.
• A collaborative and empowering work culture focused on innovation, compliance, and quality excellence.
• Opportunities for professional development and cross-functional exposure.
• The chance to contribute directly to the safety and efficacy of life-changing therapies.