Document and Training Specialist – Radio Conjugate (RC) Pharmaceutical Quality Systems (PQS)
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology
company focused on developing next generation radio conjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant innovative radio conjugate manufacturing facility to meet the demand for our growing pipeline of RCs.

The Document and Training Specialist is an entry-level position within the Quality organization responsible for supporting the day-to-day administration of the controlled document management system and the learning management system (LMS). The role ensures that Standard Operating Procedures (SOPs), Work Instructions, policies, forms, and training curricula are accurately authored, reviewed, released, assigned, and tracked in accordance with Good Documentation Practices (GDP), ALCOA+ data integrity principles, and applicable GxP regulations (GMP, GCP, GLP, GVP as relevant to the business unit).
This is an excellent opportunity for a diligent early-career professional to build a foundation in regulated-industry quality systems, working cross-functionally with subject matter experts, QA, Manufacturing, Regulatory Affairs, and Manufacturing Operations.

Process current documents, revisions, periodic reviews, and retirements within the electronic Document Management System (eDMS) (e.g., Format and Quality Checks: Review submitted documents against corporate templates and style guides for formatting consistency, correct references, hyperlink integrity, and adherence to GDP.
Change Control Interface: Link controlled document changes to associated change controls, deviations, or CAPAs in the QMS, and support impact assessments for documentation changes.
Maintain document archives in compliance with record retention schedules and regulatory requirements (e.g., LMS Administration: Create and maintain training items, curricula,



and role-based training matrices in the LMS (e.g., ComplianceWire, SuccessFactors, Cornerstone, Veeva Vault Training); assign training upon document release and monitor completion.
Training Assignment and Tracking: Generate training assignments tied to job roles, monitor overdue training, and issue compliance reports to line managers and QA leadership.
Coordinate GxP onboarding training for new employees and contractors, ensuring role-based curricula are assigned prior to independent task performance.
Training Records Integrity: Ensure training records are complete, accurate, contemporaneous, and audit-ready in line with ALCOA+ principles .
Audit and Inspection Support: Retrieve documents and training records to support internal audits, sponsor audits, and health authority inspections (FDA, EMA, MHRA, PMDA, NMPA, etc.).
Compile monthly targets for document cycle times, training compliance rates, and overdue actions, and support management review data preparation.
Process Improvement: Find opportunities to streamline document and training workflows and contribute to continuous improvement initiatives within the Quality function.

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, Information Management, Business Administration, or a related field. Advance degree is an asset.

- internships, co-op placements, or academic projects in a regulated environment (pharmaceutical, biotech, medical device, clinical research) are highly valued.
- Experience in GxP training, QMS, and document control within regulated life sciences (clinical/R&D; and/or GMP), including hands‑on audit/inspection support and validated eDMS/eLMS operations an asset.
- Exposure to GxP environments (GMP, GCP, GLP, GVP) through coursework, internship, or prior role.




- Familiarity with electronic Document Management Systems (eDMS) or Learning Management Systems (LMS) such as Veeva Vault, MasterControl, ComplianceWire, or SuccessFactors, an asset.
- Basic understanding of change control, deviation management, and CAPA processes.
- May require up to 10% travel, if applicable

Familiarity with electronic Document Management Systems (eDMS) or Learning Management Systems (LMS) such as Veeva Vault, MasterControl, ComplianceWire, or SuccessFactors.
Experience with data visualization or reporting tools (Power BI, Tableau) is a plus.
Strong technical experience with Veeva Vault (eQMS/eDMS) and UL ComplianceWire (eLMS) preferred; proficiency with Microsoft 365; familiarity with electronic signatures and Part 11/Annex 11 controls.
Solid understanding of GxP regulations and data integrity (ALCOA+); awareness of manufacturing and QC workflows; working knowledge of integration with change control, deviation, CAPA, and risk processes.
Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing View email address on careers.astrazeneca.com compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

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📌 Document Control & Training Specialist (Canada)
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