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 innovative 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).
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.
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 require up to 10% travel, if applicable
Preferred Qualifications
- Familiarity with electronic Document Management Systems (eDMS) or Learning Management Systems (LMS) such as Veeva Vault, MasterControl, ComplianceWire, or SuccessFactors.
- Awareness of 21 CFR Part 11, EU Annex 11, and ICH Q10 principles.
- Experience with data visualization or reporting tools (Power BI, Tableau) is a plus.
- Experience preparing for commercialization is advantageous.
- Systems: 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.
- Knowledge: 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.
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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 AZCHumanResources@astrazeneca.com.
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Annual base salary for this position ranges from 69,312.00 to 90,972.00.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our 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. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
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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