Quality Specialist

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:

• Training/VLearn

• Documentation/TcU/QMSIS

• NCR/CAPA (TrackWise)

• Change Control (TrackWise)

• Supplier Quality (TrackWise)

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 in Sciences/Health Sciences/Pharmacy and experience

• 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:

• 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 renal 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 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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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

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