Document and Training Specialist – Radio Conjugate (RC) Pharmaceutical Quality Systems (PQS)

Location: Hamilton, ON

Onsite 5 days/ week

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 cutting-edge radio conjugate manufacturing facility to meet the demand for our growing pipeline of RCs.

Position Summary

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).

Responsibilities

- Document Lifecycle Support: Process new documents, revisions, periodic reviews, and retirements within the electronic Document Management System (eDMS) (e.g., Veeva Vault QualityDocs, ensuring correct metadata, numbering, versioning, and workflow routing.
- 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.
- Archival and Retention: Maintain document archives in compliance with record retention schedules and regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11).
- Scanning and Filing: Ensure documentation are scanned, files in the document archive in a timely manner and all related activities have been completed.
- 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.
- New Hire Onboarding Support: 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.).
- Metrics and Reporting: 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.

Qualifications

- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, Information Management, Business Administration, or a related field. Advance degree is an asset.
- 2-5 years of relevant experience; 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.
- Organizational Skills: Ability to manage multiple concurrent requests, prioritize under deadlines, and maintain meticulous records.
- Ability to stand for longer periods of time and lift up to 40 lbs.
- May requi

📌 Document & Training Specialist, Radioconjugate PQS (Canada)
🏢 AstraZeneca
📍 Canada