Document Control Specialist I

6 months ago

Hamilton, Canada Fusion Pharmaceuticals US Inc Full time

**Fusion Pharmaceuticals (NASDAQ: FUSN)** is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.

**Position Summary**

Fusion has opened a newly created role in Quality Assurance for a Document Control Specialist I. The Document Control Specialist I will be responsible for processing and managing documents from initiation to release in the Veeva QualityDocs eDMS. This person will also be responsible for issuing batch records, worksheets, logbooks, and other requested documents to support an array of departments such as QC, Manufacturing, and Quality Assurance. This role will report to the Director or Associate Director of Site Quality.

**Key Responsibilities**
- Facilitate the life cycle of controlled documents in the electronic document management system (document creation, revision, archival, retention and withdrawal/retirement).
- Processing documents undergoing Document Change Control (assignment, tracking, closure) to ensure adherence to regulatory requirements and current site practices
- Issuance of batch records, logbooks, worksheets, and other requested GxP documents to support QC, clinical, and commercial manufacturing.
- Maintenance of Procedural Document Binders or electronic equivalent.
- Electronically scan and physically file executed documents / records such as batch records, protocols, and etc. to their designated location.
- Maintain Document Control file rooms to ensure they are organized, structured, and locations identified to ensure documents / records are preserved, retrievable and accessible in a timely manner.
- Responsible for ensuring that GMP records are maintained, secure, and retrievable throughout defined retention periods. This may include document archival and or retrieval at off-site storage per cGMP regulations.
- Support the document periodic review process.
- Ensure daily activities adhere to the documented quality system and current regulatory requirements.
- May participate in cross-functional project teams as a department representative.
- May provide support with regulatory audits and inspections as required.
- Perform other duties and responsibilities as assigned.

**Required Qualifications**
- Bachelor’s degree or equivalent experience
- 2+ years of experience in FDA regulated environment e.g. pharmaceutical, biotech, or medical device and experience in using an electronic document management system (eDMS)
- Knowledge of understanding of Quality Systems and applicable GMP regulations and standards
- Demonstrated ability to perform detail-oriented work with a high degree of accuracy
- Effective written and oral communication skills
- Effective time management and interpersonal skills
- Possesses initiative and is proactive
- Knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe
- Must work effectively within teams with rapidly changing priorities
- Builds productive internal and external working relationships

Fusion requires all employees to be current with their COVID vaccination requirements.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

  • Document Control Specialist

    5 months ago

    Hamilton, Canada Heddle Marine Service Inc Full time

    **Position Summary**: The Document Control Specialist plays a crucial role in managing all project’s related documentation, ensuring documents are recorded/filed, as well as up to date, and that proper procedures for documentation are developed and are within compliance. **Responsibilities**: - Establish and maintain a comprehensive document control...

  • Microbiologist I, Quality Control

    6 months ago

    Hamilton, Canada OmniaBio Full time

    **Reports to**:Microbiology Supervisor,** **Quality Control **Position Summary**: As Microbiologist I, Quality Control, at OmniaBio, you are a motivated individual in the field of quality control (QC) microbiology for Good Manufacturing Practices (GMP) manufacturing. The QC team is responsible for all aspects of QC for the organization and the...

  • Associate I, Quality Control

    6 months ago

    Hamilton, Canada OmniaBio Full time

    **Position Summary**: As the Associate I, Quality Control at OmniaBio, you are a motivated individual with a keen interest in the field of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products, driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The...

  • CNC & Machine Specialist

    6 months ago

    Hamilton, Canada I-Cubed Industry Innovators Inc. Full time

    Job Description All personnel at I-Cubed and Southport are required to work hard, enjoy their work and be skilled at what they do. The CNC & Machine Specialist is key member of the machine shop team and is responsible for producing machined parts by programming, setting up, and operating a computer numerical control (CNC) machine and/or conventional milling...

  • Robotics & Controls Specialist

    6 months ago

    Hamilton, Canada Radian Robotics Full time

    Reporting to the Controls Manager, the Controls Specialist will support projects and field services activities including programming and documentation. **Duties & Responsibilities** - Offline programming of robotic systems comprising of the following elements: - PLC (Siemens, Allen Bradley, & Beckhoff) - Robot (ABB) - HMI (Siemens & Allen Bradley) - Vision...

  • Electronics Field Specialist

    2 weeks ago

    Hamilton, Ontario, Canada Tabreed Thermal Control Limited Full time

    About the RoleWe are seeking an experienced Electronics Field Specialist to join our team at Tabreed Thermal Control Limited. The successful candidate will have a strong background in electronics and be able to work independently, performing various tasks related to electronic equipment service and repair.Key ResponsibilitiesInspect and test electronic...

  • Quality Control Specialist

    6 months ago

    Hamilton, Canada Lafarge Canada Full time

    Whatever you do, you'll make a difference at Lafarge Canada. Because we know that your passion and curiosity are the natural resources the world needs. Thanks to our teams' energy, commitment and ideas, we are reinventing how the world builds to make Canada greener and smarter for all. Quality Control Specialist **Requisition...

  • Electrical Appliances Repair Specialist

    3 weeks ago

    Hamilton, Ontario, Canada Tabreed Thermal Control Limited Full time

    Job Title: Electrical Appliances Repair SpecialistWe are seeking a skilled and experienced Electrical Appliances Repair Specialist to join our team at Tabreed Thermal Control Limited.

  • Electronics Maintenance Specialist

    2 weeks ago

    Hamilton, Ontario, Canada Tabreed Thermal Control Limited Full time

    Job DescriptionWe are seeking a skilled Electronics Maintenance Specialist to join our team at Tabreed Thermal Control Limited. As an Electronics Maintenance Specialist, you will be responsible for inspecting and testing electronic equipment and assemblies, diagnosing and locating circuit, component, and equipment faults, and adjusting, aligning, replacing,...

  • Electronics Installation Specialist

    2 weeks ago

    Hamilton, Ontario, Canada Tabreed Thermal Control Limited Full time

    Job OverviewWe are seeking an experienced Electronics Installation Specialist to join our team at Tabreed Thermal Control Limited.Salary and BenefitsThe successful candidate will be offered a competitive salary of $80,000 - $110,000 per year, depending on experience. In addition to the base salary, we also offer a comprehensive benefits package, including...

  • Industrial Refrigeration Specialist

    2 weeks ago

    Hamilton, Ontario, Canada Tabreed Thermal Control Limited Full time

    Job SummaryWe are seeking a highly skilled Industrial Refrigeration Specialist to join our team at Tabreed Thermal Control Limited. The successful candidate will be responsible for installing, maintaining, and repairing refrigeration systems across various industries.

  • Control Systems Specialist

    2 months ago

    Hamilton, Canada JNE Consulting Ltd. Full time

    JNE Consulting is a full-service, multi-disciplinary engineering services firm headquartered in Hamilton, Ontario with offices in Pittsburgh, PA, and Livonia, MI. Our experienced and specialized teams work globally with a diverse client base, from concept through to engineering and procurement, as well as construction and project management services. What...

  • Senior Internal Controls Specialist

    2 weeks ago

    Hamilton, Ontario, Canada McMaster University Full time

    **About McMaster University**Mcmaster university is a world-renowned institution of higher learning, with a strong reputation for academic excellence and innovation.**Job Title:** Senior Internal Controls Specialist**Salary:** $80,000 - $100,000 per year**Location:** Hamilton, ONAbout the JobWe are seeking an experienced Senior Internal Controls Specialist...

  • Electrical Appliance Repair Specialist

    2 weeks ago

    Hamilton, Ontario, Canada Tabreed Thermal Control Limited Full time

    Job DescriptionWe are seeking a skilled Electrical Appliance Repair Specialist to join our team at Tabreed Thermal Control Limited. This is a permanent, on-the-road position with a 40 to 44 hour work week and dental plan benefits.

  • Robotics & Controls Specialist

    4 months ago

    Hamilton, Canada Radian Robotics Full time

    Reporting to the Controls Manager, the Controls Specialist will support projects and field services activities including programming and documentation.Duties &...

  • Research Coordinator

    5 months ago

    Hamilton, Canada McMaster University Full time

    **Schedule** 8:30am to 4:30pm, Monday to Friday **Education Level** Bachelor's degree in a relevant field of study **Career Level** Experienced **Research Coordinator (I)** **JD 0437** Unit/Project Description: The Research Coordinator (I) will join the prestigious and highly productive Cochrane Canada/MacGRADE team (canada.cochrane.org). This...

  • Confidential Document Destruction Specialist

    3 weeks ago

    Hamilton, Ontario, Canada Stericycle Full time

    About the Role:The Confidential Document Destruction Specialist is responsible for providing exceptional service to clients while ensuring all customer document destruction needs are met.This involves safely transporting supplies and materials, adhering to company policy and local/federal laws. The specialist will load/unload delivery vehicles, securing...

  • Research Coordinator

    5 months ago

    Hamilton, Canada McMaster University Full time

    **Schedule** 8:30am-4:30pm, Monday to Friday **Education Level** Bachelor's degree in a relevant field of study **Career Level** Requires 4 years of relevant experience **JD #** JD00437 **Pay Grade**: 8 **Title**: Research Coordinator (I) **Unit/Project Description**: - For Department use only._ We have an exciting opportunity for a **Research...

  • Research Coordinator

    5 months ago

    Hamilton, Canada McMaster University Full time

    **Schedule** 8:30am-4:30pm, Monday to Friday **Education Level** Bachelor's degree in a relevant field of study **Career Level** Requires 4 years of relevant experience **JD #** JD00437 **Pay Grade**: 8 **Title**: Research Coordinator (I) **Unit/Project Description**: - For Department use only._ Join our the **McMaster Trauma Research Group** in the...

  • Research Coordinator

    5 months ago

    Hamilton, Canada McMaster University Full time

    **Schedule** 35 hours per week, 7 hours per day, Monday to Friday, 8:30am to 4:30pm **Education Level** Bachelors Degree **Career Level** 4 years of relevant experience **JD #** JD00437 **Pay Grade**: 8 **Title**: Research Coordinator (I) **Unit/Project Description**: We have an exciting opportunity for a Research Coordinator (I) to join our...