{"id":4322360,"url":"https://alion.io/job/catalent-quality-management-system-specialist","title":"Quality Management System Specialist","company":{"id":1785256,"name":"Catalent","domain":"catalent.com","url":"https://alion.io/company/catalent-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Canada"],"countries":["CA"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":56000,"max":65000,"currency":"CAD","period":"year","gross":null,"usd_annual":45573},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":true},{"name":"Outlook","optional":true}],"status":"live","first_seen_at":"2026-10-26T00:00:00Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-11-15T04:04:23Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"About Site\nThe newly launched manufacturing facility on Adair Blvd marks a pivotal expansion of Catalent’s Zydis® technology, a globally renowned, fast-dissolve oral dosage form that has transformed the lives of millions of patients worldwide. This is your opportunity to join a dedicated team at the forefront of pharmaceutical manufacturing. At Adair, you’ll play a vital role in the startup of a site built for innovation and excellence, from installation and qualification to regulatory approval and commercial manufacturing.\nPosition Summary\nWe have an opportunity for a Quality Management System Specialist to join our team. In this role, you will maintain the company’s quality management systems to ensure compliance with Good Manufacturing Practices. You will organize and conduct assessments related to suppliers, product complaints, internal compliance, and change control. This position plays a key role in fostering a culture of continuous improvement and operational excellence at the Adair site.\nShift: Monday - Friday, 8:00 AM - 4:30 PM or 8:30 AM - 5:00 PM with a 30-minute\nLocation: Adair, ON\n100% Onsite\nThe Role\nParticipate in various quality system areas, including customer regulatory inquiries, change control, document control, and metrics provision.\nMaintain the facility’s supplier assessment program, reviewing supplier audit reports, complaints, and material reviews.\nLead the internal audit schedule, support self-inspections, review audit reports, and assist with regulatory and customer audits to ensure compliance and inspection readiness.\nSupport the preparation of Quality Systems trend reports, provide recommendations based on observed trends, and lead or support continuous improvement initiatives.\nParticipate in investigations and corrective action identification or implementation for deviations and complaint documentation, ensuring timely closure.\nConduct compliance reviews of site and corporate procedures and support quality improvement initiatives by participating in project teams and executing assigned projects.\nDevelop the Quality Management System for optimal efficiency by leading small teams through the implementation of new systems and ways of working.\nPerform other duties as required.\n\nThe Candidate\nMinimum Requirements\nDiploma or bachelor’s degree in life science or related field required.\nMinimum of 2 years of experience in Quality, Operations, or related field required.\nExperience working in a regulated manufacturing environment required.\nPrevious experience in Quality Management System, preferably within the pharmaceutical industry, is highly desirable.\nExperience in preparation and involvement relating to FDA and HPFBI inspections is desirable.\nWhile performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to sit and use their hands and fingers to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required. The employee is occasionally required to stand, walk, reach with arms and hands, bend, twist, stoop, kneel, crouch, or crawl. Vision abilities required include close vision.\nPreferred Skills & Background\nKnowledge of Good Manufacturing Practice compliance and regulatory requirements with a strong understanding of quality systems.\nExperience in generating controlled documents.\nStrong attention to detail and a high degree of accuracy.\nExcellent organizational and time management skills to prioritize tasks, allocate resources effectively, and meet schedules.\nDemonstrated ethics and due diligence.\nThis position does not qualify for sponsorship.\nCandidates with non-Canadian credentials must provide an evaluation confirming the Canadian equivalency of the credentials as determined by the Alliance of Credential Evaluation Services of Canada (ACESC) such as World Education Services.\nExcellent communication (written and verbal) and interpersonal skills.\nStrong computer skills including Microsoft Office Suite (Outlook, Excel, PowerPoint, Word) and familiarity with quality management systems and related software is advantageous.\nAbility to respond quickly to a changing regulatory environment.\nPay\nThe final salary offered to a successful candidate may vary within this range $56,000 - $65,000, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a global employer, and this salary range does not reflect positions that work in other countries.\nWhy You Should Join Catalent\nComprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)\nGroup Retirement Savings - Registered Pension Plan (RPP) with employer contributions\nEmployee Reward & Recognition programs\nOpportunities for professional and personal development & growth including tuition reimbursement\nCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.\npersonal initiative. dynamic pace. meaningful work.\nVisit Catalent Careers to explore career opportunities.\nCatalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.\nIf you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.\nNotice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. 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