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.