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Added 9 mins ago
IP
Operational Excellence Analyst
InterPro Pipe + Steel
Camrose, AB
- Full-time
Industrial or Manufacturing Engineer, Engineering Technologist, other engineering disciplines will be considered, bachelor’s degree in engineering, preferred
Added 9 mins ago
IP
Operational Excellence Analyst
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- Full-time
Industrial or Manufacturing Engineer, Engineering Technologist, other engineering disciplines will be considered, bachelor’s degree in engineering, preferred
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Project Manager II
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- Full-time
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Railway Infrastructure Specialist
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- Full-time
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Human Factors Specialist
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Mississauga, ON
- Part-time
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Packaging Planning Specialist
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Cambridge, ON
- $45.67 to $50 CAD / hour
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Added 1 hour ago
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Information Security Specialist
Nityo Infotech
Toronto, ON
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Role Title: Information Security Specialist (Segregation of Duties)
Added 1 hour ago
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Senior Technical Support Specialist
XR Extreme Reach
Toronto, ON
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Added 1 hour ago
ML
MRO Coordinator
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ON · Hannon, ON
- $47,000 to $69,000 CAD / year
- Full-time
The MRO Coordinator is an experienced MRO specialist with at least 3 years of experience in an inventory, warehousing or purchasing management role applying proven MRO best practices in an…
Added 1 hour ago
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Senior Data Engineer
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Toronto, ON · Waterloo, ON · Sun Life Toronto One York
- Full-time
…Life’s Information Security organization is enhancing its data engineering, platform, analytics, and insights capabilities through new tools and, most importantly, new…
Added 2 hours ago
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Document & Training Specialist, Radioconjugate PQS
AstraZeneca
Hamilton, ON · Canada – Hamilton – Longwood Road South
- Full-time
Document and Training Specialist – Radio Conjugate (RC) Pharmaceutical Quality Systems (PQS)
Added 2 hours ago
Specialist - Engineering Change Analyst
L3Harris Technologies
ON · Waterdown, ON
Job Title: Specialist, Engineering Change Analyst
Added 2 hours ago
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HSE Specialist
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- Full-time
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Talent Acquisition and Development Specialist (Saas) - Technical & Sales
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Toronto, ON · North York, ON
- $50,000 to $55,000 CAD / year
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Starting with the most urgent hiring needs across Sales and Engineering you will work closely with leadership to deliver a seamless, high-quality candidate and employee experience. This…
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As a Steel Building Design & Production Specialist, you will play an important role in connecting the technical aspects of our building solutions with our sales and project coordination…
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Specialist - Cable Routing and Low-Voltage Systems
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Montreal, QC
- Full-time
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Added 3 hours ago
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Spécialiste des tests système / System Test Specialist
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Remote, Canada
- Full-time
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Added 3 hours ago
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Spécialiste des tests système / System Test Specialist
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Software Dev QA Specialist
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Burnaby, BC
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Added 3 hours ago
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Technical Specialist, Wastewater Treatment
AECOM
Markham, ON · Mississauga, Ontario
- $200,000 to $250,000 CAD / year
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Added 3 hours ago
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Operational Excellence Analyst
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AstraZeneca

Document & Training Specialist, Radioconjugate PQS

Hamilton, ON, Canada
Canada – Hamilton – Longwood Road South, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Nov 11, 2026
Posting language: English
Posted: Oct 28, 2026

Original job description

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.

Great People want to Work with us! Find out why:

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 AZCHumanResources@astrazeneca.com.

⠀

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.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

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More about this job

Responsibilities

The Document and Training Specialist manages the lifecycle of controlled documents and administers the learning management system to ensure GxP compliance. They also support audit readiness by maintaining accurate training records and coordinating onboarding for new personnel.

Requirements

Candidates must hold a bachelor's degree in a relevant field and possess 2-5 years of experience in a regulated environment. Proficiency in document control systems and a solid understanding of GxP regulations and data integrity principles are required.

Skills

Document Management
Learning Management Systems
GxP
GMP
Quality Assurance
Data Integrity
ALCOA+
Change Control
CAPA
Regulatory Compliance
Veeva Vault
ComplianceWire
Technical Writing
Audit Support
Document Control

Benefits

Flex Benefits
Retirement Savings Program
Paid Vacation
Personal Days
Variable Pay Bonus
Short Term Incentive
Equity-based Long-term Incentive

Visa sponsorship

Not detected in the job text

Keywords

Document Management System
Learning Management System
GxP
GMP
GCP
GLP
GVP
ALCOA+
Data Integrity
Veeva Vault
ComplianceWire
SuccessFactors
Cornerstone
MasterControl
Change Control
CAPA
Deviation Management
21 CFR Part 11
EU Annex 11
ICH Q10
Power BI
Tableau
Quality Assurance
Regulatory Affairs
Oncology
Radio Conjugates
Clinical Trials
Documentation Practices
Audit Support
Quality Management System

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