Quality Specialist (12 Months Maternity Contract)
About The Position
Vantive is a vital organ therapy company focused on extending lives and expanding possibilities for patients and care teams. With a 70-year legacy in kidney care, Vantive is deepening its commitment to elevating the dialysis experience through digital solutions and advanced services, while also investing in transforming vital organ therapies beyond kidney care. The company aims to deliver greater flexibility and efficiency in therapy administration for care teams and longer, fuller lives for patients. Vantive seeks individuals who are focused, courageous, and driven to improve patients' lives worldwide to join their community and advance their mission.
Requirements
- University degree and/or applicable post-secondary education and experience.
- Major Subjects: Sciences/Health Sciences/Pharmacy.
- 1-2 years working in a regulated industry.
- General knowledge of Quality systems in a GMP environment (NCR/CAPA, Change Control, Documentation, Training).
- SOP/Technical Writing experience.
- Working in IT systems.
- Critical thinking in the context of leading/performing strong investigations into nonconforming events.
- Strong communication and Technical Writing Skills.
- Strong problem solving skills and the ability to take the initiative.
- Self-motivated, self-directed and enthusiastic.
- Ability to multi-task across many areas.
- Computer skills (Quality IT systems and Microsoft applications).
- Ability to work well and build relationships with internal partners.
Nice To Haves
- University degree in Sciences/Health Sciences.
- 1-2 years working in the healthcare industry under Health Canada GMP requirements.
- Strong knowledge of Health Canada GMPs and guidances.
- Strong understanding of Health Canada GMPs and Medical Device regulations.
- Knowledge of Vantive products and therapies.
- Project Management experience.
Responsibilities
- Ongoing review and governance of the TrackWise (TW) system for NCR/CAPA and Change Control, ensuring timely completion of records in accordance with Global requirements.
- Create slide decks and participate in monthly CAPA and Change Control review boards.
- Act as lead investigation owner for local nonconformance investigations, as required.
- Support the timely execution and closure of local change controls.
- Assist in uploading SOPs and documentation into TcU; track and communicate periodic reviews.
- Support new hire training assignments, as required.
- Support biennial Training Matrix review.
- Support training content creation.
- Monitor coming due and past due training.
- Support Supplier Quality activities for UCAN, including new supplier requests, supplier updates, and requirement reviews.
- Support clean-up efforts to maintain SQLM in a current and compliant state.
- Support distribution complaint investigations, tracking, and closure.
- Support returns dispositions, tracking, and closure.
- Support JDE item and lot master changes.
- Support QMSIS activities, ensuring Global requirements are implemented locally.
- Support ongoing maintenance of the QA/RA Sharepoint Site.
Benefits
- Flexible workplace policy with a minimum of 2 days a week onsite.
- Equitable pay practices.
- Discretionary bonuses.
- Opportunities for growth and learning to advance career.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
