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Added 4 hours ago
Spécialiste en configuration / Coordonnateur de l'amélioration continue / Configuration Specialist
LeadsOnline
Montreal, QC
…internes, la coordination des actions correctives et préventives (CAPA), l'analyse des causes profondes et la gestion des dérogations…
Added 7 hours ago
MI
Process Quality Lead
Mondelēz International
Toronto, ON · Plant - Gladstone - Toronto, Canada
- Full-time
Coordinate the workload for the Senior Quality Specialist and Quality Specialist to support the activities on the manufacturing floor to ensure Finished Product and WIP are produced within…
Added 10 hours ago
AG
CQV Specialist/Metrologist
AtomVie Global Radiopharma Inc.
Hamilton, ON
- Full-time
Reporting to the Engineering Manager as a CQV Specialist, assist the Engineering department focused on laboratory equipment qualifications, calibrations, recertifications, and documentation…
Added 13 hours ago
JP
Senior Specialist, Microbiology & Environmental Monitoring
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Job Title: Senior Specialist, Microbiology & Environmental Monitoring
Added 13 hours ago
JP
Specialist, Compliance
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
The Specialist, Compliance supports the Quality Systems & Compliance function by monitoring,maintaining, and strengthening site compliance with GMP and regulatory requirements.This role…
Added 13 hours ago
JP
Specialist, Compliance
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
We are seeking a detail-oriented and collaborative Specialist, Compliance to join our Quality team. In this role, you will support the maintenance and continuous improvement of our Quality…
Added 13 hours ago
JP
Senior Manager, Environmental Monitoring & Microbiology
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
The Specialist acts as a key quality partner to Operations by assessing EM risks, supporting investigations, trending data, and recommending scientifically sound corrective actions to…
Added 13 hours ago
JP
Maintenance Technical Specialist, Equipment and Documentation
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Job Title: Maintenance Technical Specialist, Equipment and Documentation
Added 13 hours ago
JP
Specialist, Sourcing, R&D and New Product Introduction
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Job Title: Specialist, Sourcing, R&D and New Product Introduction
Added 13 hours ago
JP
Validation Specialist
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
The Validation Specialist is responsible for developing, coordinating, and executing qualification and validation activities related to equipment, systems, utilities, cleaning processes,…
Added 13 hours ago
JP
Spécialiste, Validation AQ et gouvernance des données / Specialist, QA Validation & Data Governance
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Job Title: Spécialiste, Validation AQ et gouvernance des données / Specialist, QA Validation & Data Governance
Added 1 day ago
Quality and Compliance Specialist - Supply Chain
GoodMorning
Edmonton, AB
As a Quality and Compliance Specialist Supply Chain at GoodMorning.com, this role serves as a subject-matter specialist for supplier quality, product compliance, and quality assurance…
Added 1 day ago
ML
FSQA Supervisor/HACCP Specialist
Maple Leaf Foods Inc.
Toronto, ON · North York, Ontario
- $62,000 to $91,000 CAD / year
- Full-time
Lead cross functional teams in completing incident investigations where food safety or food quality may be compromised including Root Cause and CAPA.
Added 1 day ago
II
Quality Engineer
Intero Integrity
Toronto, ON
- Full-time
Thanks to our growth, we have a newly created position for a Quality Engineering Specialist.
Added 2 days ago
LC
Senior Specialist, Quality Assurance
Loblaw Companies Limited
Toronto, ON
- Full-time
Must have a Bachelor of Science (or Canadian Equivalent)
Added 2 days ago
SD
Senior Specialist, Quality Assurance
Shoppers Drug Mart
Toronto, ON
- Full-time
Must have a Bachelor of Science (or Canadian Equivalent)
Added 2 days ago
S
Quality Control Specialist
Stella-Jones
Gatineau, QC
- Full-time
Reporting to the Quality Assurance Supervisor, the Quality Control Specialist plays a vital role in ensuring that Stella-Jones facilities consistently meet company, industry, and…
Added 2 days ago
Clinical Nurse Specialist, Specific Care Clinic & Halifax CMHA
Nova Scotia Health and IWK Health
Halifax, NS
Reporting to the Manager of Community Mental Health, the Clinical Nurse Specialist will work with children, youth and families, utilizing the Choice and Partnership Approach (CAPA) to…
Added 2 days ago
Inventory Specialist
NDT Global Group
Leduc, AB
The goal of the Inventory Specialist is to execute, coordinate, and support the business by establishing, maintaining, and optimizing our global inventory system. At this level, the job…
Added 3 days ago
JR
Spécialiste, Approvisionnement , R&D et Introduction de Nouveaux Produits / Specialist, Sourcing, R&D and New Product Introduction
Jubilant Radiopharma
Kirkland, QC
- Full-time
Assurer la gestion des CAPA et des retours fournisseurs sous sa responsabilité.
Added 4 days ago
RL
Customer Quality Technologist (6 months assignment)
Romet Limited
ON · Mississauga, ON
- Full-time
Added 5 days ago
SL
QA/QC
SaniHealth Labs Inc.
Hamilton, ON
- Full-time
We are seeking a detail-oriented QA/QC Specialist to join our Quality Department and support daily manufacturing operations, quality control testing, and regulatory compliance.
Added 5 days ago
JR
Compliance Specialist
Jubilant Radiopharma
Kirkland, QC
- Full-time
We are seeking a detail-oriented and collaborative Specialist, Compliance to join our Quality team. In this role, you will support the maintenance and continuous improvement of our Quality…
Added 6 days ago
TP
Microbiology Specialist (Environmental Monitoring & Sampling) - 24 month contract
Teva Pharmaceuticals
Toronto, ON
- Full-time
Microbiology Specialist (Environmental Monitoring & Sampling)
Added 6 days ago
J
Senior Quality Assurance Specialist - Consultant
Jobgether
Canada
- Full-time
…steps. Our partner is looking for a Senior Quality Assurance Specialist - Consultant based in…

AstraZeneca

Document & Training Specialist, Radioconjugate PQS

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

Full-time

Apply on astrazeneca.wd3.myworkdayjobs.com About employer

Applications open in a new tab.

Job details

Job type: Full-time
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.

Apply on astrazeneca.wd3.myworkdayjobs.com About employer

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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Work requirements

Jobs in Canada