Senior QA Associate

OverviewEurofins 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.Are you passionate about quality and innovation in pharmaceutical manufacturing? At Eurofins CDMO Alphora Inc., we’re looking for a Senior QA Associate to be a key player in our Biologics and Fill Finish operations. This is more than a job—it’s a chance to make a real impact on the development of life-changing therapies for patients around the world.In this role, you’ll be at the forefront of ensuring compliance with Current Good Manufacturing Practices (cGMP), supporting the production of safe and effective clinical and commercial biologics. You’ll work closely with cutting-edge technologies and products, including monoclonal antibodies (mAbs), therapeutic proteins, and antibody drug conjugates (ADCs).What makes this opportunity exciting?Hands-on experience in biologics manufacturing and fill-finish operationsExposure to projects across all phases of the pharmaceutical product lifecycleA dynamic, fast-paced environment where learning and growth are constantThe chance to tackle unique challenges and contribute to meaningful solutionsWhat You’ll do:Quality Oversight: Production line clearance; Batch manufacturing and final product packaging operation oversight; Change control management; Logbook management; GDP oversight; Participate/lead quality oversight initiatives as assigned.Batch Review and Release: Review executed batch records and equipment cleaning records; Batch disposition assignment; Preparation of batch certificatesTesting Data Review and Release: Review/approve cGMP analytical data supporting reference standard qualification and method qualification/validation; Review/approve quality control lab data for raw materials, in-process controls, intermediates and APIs; Assign disposition to laboratory samplesDeviations and Investigations: Support deviation investigations and laboratory investigations; Development of investigation plans; Conducting investigations; Root cause analysis; Risk and impact assessments; CAPA determinationQMS Support: Contribute to QMS development and continuous improvement; Contribute to writing and review of over Standard Operating Procedures (SOPs).Audit Support: Assist in preparation/coordination of customer and regulatory agency audits.Contribute to QA department meetings by providing project status reports as well as identifying and leading continuous improvement activitiesParticipate in opportunities to develop knowledge of CGMP and business operationsQualificationsBSc; specialization in Biochemistry, Microbiology, or related discipline is preferred2-5 years of pharmaceutical quality experienceExperience with development, manufacture, packaging and testing of pharmaceuticalsStrong understanding of cGMP and related RegulationsExperience with Biologic pharmaceutical, in particular mAbs and ADCs is an assetSterile fill / aseptic processing experience preferred.Strong written and verbal skills are a priorityA proficiency for multi-taskingExcellent interpersonal skillsGood time management and project management skillsA focus on attention to detailBe goal orientated and results drivenA desire to learn and for continuous developmentAdditional InformationAt Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at Eurofins.ca.As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at Eurofins.caWe thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.This posting is supported by AI technology to assist in screening candidates and resumes.NO AGENCIES, CALLS OR EMAILS PLEASE #J-18808-Ljbffr