QA Associate – Biologics - Eurofins CDMO Alphora, Inc.

Google Chrome Microsoft Edge Apple Safari Mozilla Firefox QA Associate – Biologics - Eurofins CDMO Alphora, Inc.Full-time Compensation: up to CAD 70000 - yearlyCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.In 2025, Eurofins generated total revenues of EUR 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years.Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients.  Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -“API’s”) as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements.  Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects.  Our employees work in close concert with clients throughout the development process to achieve their program objectives.  Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.Job DescriptionThe QA Associate – Biologics is accountable to the QA Manager, Biologics and plays a key role in supporting Eurofins CDMO Alphora Inc.’s compliance with Current Good Manufacturing Practices (cGMP) to ensure the production of safe and efficacious clinical and commercial pharmaceuticals on behalf of our clients and their patients.The QA Associate – Biologics supports quality oversight of GMP activities within the Biologics operating unit, including the development and commercialization of biotechnology-derived pharmaceuticals such as monoclonal antibodies (mAbs), mammalian-based therapeutic proteins, and antibody-drug conjugate (ADC) candidates. Biologics GMP operations include a clinical GMP cleanroom suite, GMP analytical/QC laboratory, and large-scale GMP manufacturing facility with sterile fill-finish capabilities.DUTIES AND RESPONSIBILITIES:Support the QA Manager, Biologics in providing quality oversight for GMP activities across the Biologics operating unit, including facilities, bulk processing operations, fill-finish operations, and analytical activities.Quality OversightProvide production support including equipment and line clearances.Perform oversight of batch manufacturing and final product packaging operationsSupport the review/assess change controls.Perform logbook issuance, reconciliation and routine GDP inspectionsSupport the development and implementation of the Environmental Monitoring Program and...