Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Your Role:
To assist in managing the following major Quality System processes and systems to ensure a state of control and compliance:
What you'll be doing:
NCR/CAPA
Ongoing review and governance of TW system; responsible for ensuring that records are completed in a timely manner and in accordance with Global requirements
Create slide decks and participate in monthly CAPA review boards
Act as lead investigation owner for local nonconformance investigations, as required
Change Control
Ongoing review and governance of TW system; responsible for ensuring that records are completed in a timely manner and in accordance with Global requirements
Create slide decks and participate in monthly Change Control review boards
Support the timely execution and closure of local change controls
Training and Documentation
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
Monitoring coming due and past due training
Supplier Quality
Support Supplier Quality activities for UCAN (ie. New supplier requests, supplier updates, requirement reviews, etc)
Support clean-up efforts to maintain SQLM in a current and compliant state
Other
Support distribution complaint investigations, tracking and closure
Support returns dispositions, tracking and closure
Support JDE item and lot master changes
Support QMSIS activities, ensuring that Global requirements are implemented locally
Support ongoing maintenance of the QA/RA Sharepoint Site
What you'll bring:
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 have:
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
Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 2 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $60,000 to $70,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Existing Position: Yes — this role is a temporary position to cover a maternity leave.
Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link
Recruitment Fraud Notice
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