**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. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.