14 часов назад
Quality Specialist (12 Months Maternity Contract)
60 000 - 70 000CAD
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Specialist (12 Months Maternity Contract) (GMP/Quality Systems): Managing and maintaining quality system processes for a vital organ therapy company with an accent on NCR/CAPA, change control, training, documentation, and supplier quality. Focus on leading nonconformance investigations, governing TrackWise records, supporting regulatory compliance, and coordinating quality activities across internal partners and suppliers.
Location: Mississauga, Ontario, Canada; minimum 2 days per week onsite
Salary: CAD 60,000–70,000 annually, with potential discretionary bonuses
Company
develops vital organ therapy solutions, including kidney care, dialysis services, digital solutions, and advanced therapies.
What you will do
- Manage and govern NCR/CAPA records in TrackWise, ensuring timely completion and compliance with global requirements.
- Lead local nonconformance investigations and participate in monthly CAPA review boards.
- Govern change control records, support local change execution and closure, and participate in review boards.
- Upload and maintain SOPs and documentation, monitor training status, support onboarding assignments, and review training matrices.
- Support supplier quality activities, including new supplier requests, supplier updates, requirement reviews, and SQLM maintenance.
- Track complaint investigations, returns dispositions, QMSIS activities, JDE master changes, and QA/RA SharePoint maintenance.
Requirements
- University degree or relevant post-secondary education and experience, preferably in sciences, health sciences, or pharmacy.
- 1–2 years of experience in a regulated industry.
- General knowledge of quality systems in a GMP environment, including NCR/CAPA, change control, documentation, and training.
- Experience with SOP or technical writing and quality IT systems.
- Strong critical thinking, investigation, problem-solving, communication, and technical writing skills.
- Ability to manage multiple areas independently and build relationships with internal partners.
Nice to have
- Experience in healthcare under Health Canada GMP requirements.
- Strong knowledge of Health Canada GMPs, guidances, and medical device regulations.
- Knowledge of products and therapies.
- Project management experience.
Culture & Benefits
- Flexible workplace policy combining remote flexibility with in-person collaboration.
- Minimum two onsite days per week.
- Temporary maternity-leave coverage for a 12-month contract.
- Reasonable accommodations are available throughout the application and interview process.
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